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Biochemistry of the Coagulation Cascade and Platelet Aggregation: Nitric Oxide: Platelets, Circulatory Disorders, and Coagulation Effects

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Biomarkers & Medical Diagnostics, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Coagulation Therapy and Internal Bleeding, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Metabolomics, Mitral Valve: Repair and Replacement, Nitric Oxide in Health and Disease, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Industry Competitive Intelligence, Pharmacotherapy of Cardiovascular Disease, Population Health Management, Nutrition and Phytochemistry, Proteomics, tagged anti-inflammatory, anti-TNF, Anticoagulant, Antithrombin, blood flow resistance, cell junctions, cellular adhesion, Coumadin, Endothelial cells, Factor IX and IXa, Factor VII and VIIa, Factor VIII and Factor VIIIa, Factor X and Xa, fibrinogen, fibrinolysis, heparin, Hypoxia-inducible factors, Non-steroidal anti-inflammatory drug, Partial thromboplastin time, Physiology, plasmin, platelet aggregation, platelets, prothrombin, soluble fibrin, subendothelial matrix, Thrombin, thrombomodulin, Thrombus, tissue factor, TNF-a, Von Willebrand factor, WH Seegers on November 26, 2012| 4 Comments »

Biochemistry of the Coagulation Cascade and Platelet Aggregation: Nitric Oxide: Platelets, Circulatory Disorders, and Coagulation Effects

Curator/Editor/Author: Larry H. Bernstein, MD, FCAP

Thrombin & Coagulation Cascade

Word Cloud Created by Noam Steiner Tomer 8/10/2020

Subtitle: Nitric Oxide: Platelets, Circulatory Disorders, and Coagulation Effects. (Part I)

Summary: This portion of the Nitric Oxide series on PharmaceuticalIntelligence(wordpress.com) is the first of a two part treatment of platelets, the coagulation cascade, and protein-membrane interactions with low flow states, local and systemic inflammatory disease, and hematologic disorders. It is highly complex as the lines separating intrinsic and extrinsic pathways become blurred as a result of endothelial shear stress, distinctly different than penetrating or traumatic injury. In addition, other factors that come into play are also considered. The 2^nd piece will be concerned with oxidative stress and the diverse effects on NO on the vasoactive endothelium, on platelet endothelial interaction, and changes in blood viscosity.

Coagulation Pathway

The workhorse tests of the modern coagulation laboratory, the prothrombin time (PT) and the activated partial thromboplastin time (aPTT), are the basis for the published extrinsic and intrinsic coagulation pathways. This is, however, a much simpler model than one encounters delving into the mechanism and interactions involved in hemostasis and thrombosis, or in hemorrhagic disorders.

We first note that there are three components of the hemostatic system in all vertebrates:

Platelets,
vascular endothelium, and
plasma proteins.

The liver is the largest synthetic organ, which synthesizes

albumin,
acute phase proteins,
hormonal and metal binding proteins,
albumin,
IGF-1, and
prothrombin, mainly responsible for the distinction between plasma and serum (defibrinated plasma).

According to WH Seegers [Seegers WH, Postclotting fates of thrombin. Semin Thromb Hemost 1986;12(3):181-3], prothrombin is virtually all converted to thrombin in clotting, but Factor X is not. Large quantities of thrombin are inhibited by plasma and platelet AT III (heparin cofactor I), by heparin cofactor II, and by fibrin. Antithrombin III, a serine protease, is a main inhibitor of thrombin and factor Xa in blood coagulation. The inhibitory function of antithrombin III is accelerated by heparin, but at the same time antithrombin III activity is also reduced. Heparin retards the thrombin-fibrinogen reaction, but otherwise the effectiveness of heparin as an anticoagulant depends on antithrombin III in laboratory experiments, as well as in therapeutics. The activation of prothrombin is inhibited, thereby inactivating any thrombin or other vulnerable protease that might otherwise be generated. [Seegers WH, Antithrombin III. Theory and clinical applications. H. P. Smith Memorial Lecture. Am J Clin Pathol. 1978;69(4):299-359)]. With respect to platelet aggregation, platelets aggregate with thrombin-free autoprothrombin II-A. Aggregation is dependent on an intact release mechanism since inhibition of aggregation occurred with adenosine, colchicine, or EDTA. Autoprothrombin II-A reduces the sensitivity of platelets to aggregate with thrombin, but enhances epinephrine-mediated aggregation. [Herman GE, Seegers WH, Henry RL. Autoprothrombin ii-a, thrombin, and epinephrine: interrelated effects on platelet aggregation. Bibl Haematol 1977;44:21-7.]

A tetrapeptide, residues 6 to 9 in normal prothrombin, was isolated from the NH(2)-terminal, Ca(2+)-binding part of normal prothrombin. The peptide contained two residues of modified glutamic acid, gamma-carboxyglutamic acid. This amino acid gives normal prothrombin the Ca(2+)-binding ability that is necessary for its activation.

Abnormal prothrombin, induced by the vitamin K antagonist, dicoumarol, lacks these modified glutamic acid residues and that this is the reason why abnormal prothrombin does not bind Ca(2+) and is nonfunctioning in blood coagulation. [Stenflo J, Fernlund P, Egan W, Roepstorff P. Vitamin K dependent modifications of glutamic acid residues in prothrombin. Proc Natl Acad Sci U S A. 1974;71(7):2730-3.]

Interestingly, a murine monoclonal antibody (H-11) binds a conserved epitope found at the amino terminal of the vitamin K-dependent blood proteins prothrombin, factors VII and X, and protein C. The sequence of polypeptide recognized contains 2 residues of gamma-carboxyglutamic acid, and binding of the antibody is inhibited by divalent metal ions. The antibody bound specifically to a synthetic peptide corresponding to residues 1-12 of human prothrombin that was synthesized as the gamma-carboxyglutamic acid-containing derivative, but binding to the peptide was not inhibited by calcium ion. This suggested that binding by divalent metal ions is not due simply to neutralization of negative charge by Ca2+. [Church WR, Boulanger LL, Messier TL, Mann KG. Evidence for a common metal ion-dependent transition in the 4-carboxyglutamic acid domains of several vitamin K-dependent proteins. J Biol Chem. 1989;264(30):17882-7.]

Role of vascular endothelium.

I have identified the importance of prothrombin, thrombin, and the divalent cation Ca ²⁺(1% of the total body pool), mention of heparin action, and of vitamin K (inhibited by warfarin). Endothelial functions are inherently related to procoagulation and anticoagulation. The subendothelial matrix is a complex of many materials, most important related to coagulation being collagen and von Willebrand factor.

What about extrinsic and intrinsic pathways? Tissue factor, when bound to factor VIIa, is the major activator of the extrinsic pathway of coagulation. Classically, tissue factor is not present in the plasma but only presented on cell surfaces at a wound site, which is “extrinsic” to the circulation. Or is it that simple?

Endothelium is the major synthetic and storage site for von Willebrand factor (vWF). vWF is…

secreted from the endothelial cell both into the plasma and also
abluminally into the subendothelial matrix, and
acts as the intercellular glue binding platelets to one another and also to the subendothelial matrix at an injury site.
acts as a carrier protein for factor VIII (antihemophilic factor).
It binds to the platelet glycoprotein Ib/IX/V receptor and
mediates platelet adhesion to the vascular wall under shear. [Lefkowitz JB. Coagulation Pathway and Physiology. Chapter I. in Hemostasis Physiology. In ( ???), pp1-12].

Ca++ and phospholipids are necessary for all of the reactions that result in the activation of prothrombin to thrombin. Coagulation is initiated by an extrinsic mechanism that

generates small amounts of factor Xa, which in turn
activates small amounts of thrombin.

The tissue factor/factorVIIa proteolysis of factor X is quickly inhibited by tissue factor pathway inhibitor (TFPI).The small amounts of thrombin generated from the initial activation feedback

to create activated cofactors, factors Va and VIIIa, which in turn help to
generate more thrombin.
Tissue factor/factor VIIa is also capable of indirectly activating factor X through the activation of factor IX to factor IXa.
Finally, as more thrombin is created, it activates factor XI to factor XIa, thereby enhancing the ability to ultimately make more thrombin.

Coagulation Cascade

The procoagulant plasma coagulation cascade has traditionally been divided into the intrinsic and extrinsic pathways. The Waterfall/Cascade model consists of two separate initiations,

intrinsic (contact) and
- The intrinsic pathway is initiated by a complex activation process of the so-called contact phase components,
  - prekallikrein,
  - high-molecular weight kininogen (HMWK) and
  - factor XII

Activation of the intrinsic pathway is promoted by non-biological surfaces, such as glass in a test tube, and is probably not of physiological importance, at least not in coagulation induced by trauma.

Instead, the physiological activation of coagulation is mediated exclusively via the extrinsic pathway, also known as the tissue factor pathway.

extrinsic pathways,

Tissue factor (TF) is a membrane protein which is normally found in tissues. TF forms a procoagulant complex with factor VII, which activates factor IX and factor X.

which ultimately merge at the level of Factor Xa (common pathway).

Regulation of thrombin generation. Coagulation is triggered (initiation) by circulating trace amounts of fVIIa and locally exposed tissue factor (TF). Subsequent formations of fXa and thrombin are regulated by a tissue factor pathway inhibitor (TFPI) and antithrombin (AT). When the threshold level of thrombin is exceeded, thrombin activates platelets, fV, fVIII, and fXI to augment its own generation (propagation).

Activated factors IX and X (IXa and Xa) will activate prothrombin to thrombin and finally the formation of fibrin. Several of these reactions are much more efficient in the presence of phospholipids and protein cofactors factors V and VIII, which thrombin activates to Va and VIIIa by positive feedback reactions.

We depict the plasma coagulation emphasizing the importance of membrane surfaces for the coagulation processes. Coagulation is initiated when tissue factor (TF), an integral membrane protein, is exposed to plasma. TF is expressed on subendothelial cells (e.g. smooth muscle cells and fibroblasts), which are exposed after endothelium damage. Activated monocytes are also capable of exposing TF.

A small amount, approximately 1%, of activated factor VII (VIIa) is present in circulating blood and binds to TF. Free factor VIIa has poor enzymatic activity and the initiation is limited by the availability of its cofactor TF. The first steps in the formation of a blood clot is the specific activation of factor IX and X by the TF-VIIa complex. (Initiation of coagulation: Factor VIIa binds to tissue factor and activates factors IX and X). Coagulation is propagated by procoagulant enzymatic complexes that assemble on the negatively charged membrane surfaces of activated platelets. (Propagation of coagulation: Activation of factor X and prothrombin). Once thrombin has been formed it will activate the procofactors, factor V and factor VIII, and these will then assemble in enzyme complexes. Factor IXa forms the tenase complex together with its cofactor factor VIIIa, and factor Xa is the enzymatic component of the prothrombinase complex with factor Va as cofactor.

Activation of protein C takes place on the surface of intact endothelial cells. When thrombin (IIa) reaches intact endothelium it binds with high affinity to a specific receptor called thrombomodulin. This shifts the specific activity of thrombin from being a procoagulant enzyme to an anticoagulant enzyme that activates protein C to activated protein C (APC). The localization of protein C to the thrombin-thrombomodulin complex can be enhanced by the endothelial protein C receptor (EPCR), which is a transmembrane protein with high affinity for protein C. Activated protein C (APC) binds to procoagulant surfaces such as the membrane of activated platelets where it finds and degrades the procoagulant cofactors Va and VIIIa, thereby shutting down the plasma coagulation. Protein S (PS) is an important nonenzymatic cofactor to APC in these reactions. (Degradation of factors Va and VIIIa).

The common theme in activation and regulation of plasma coagulation is the reduction in dimensionality. Most reactions take place in a 2D world that will increase the efficiency of the reactions dramatically. The localization and timing of the coagulation processes are also dependent on the formation of protein complexes on the surface of membranes. The coagulation processes can also be controlled by certain drugs that destroy the membrane binding ability of some coagulation proteins – these proteins will be lost in the 3D world and not able to form procoagulant complexes on surfaces.

Assembly of proteins on membranes – making a 3D world flat

• The timing and efficiency of coagulation processes are handled by reduction in dimensionality

– Make 3 dimensions to 2 dimensions

• Coagulation proteins have membrane binding capacity

• Membranes provide non-coagulant and procoagulant surfaces

– Intact cells/activated cells

• Membrane binding is a target for anticoagulant drugs

– Anti-vitamin K (e.g. warfarin)

Modern View

It can be divided into the phases of initiation, amplification and propagation.

In the initiation phase, small amounts of thrombin can be formed after exposure of tissue factor to blood.
In the amplification phase, the traces of thrombin will be inactivated or used for amplification of the coagulation process.

At this stage there is not enough thrombin to form insoluble fibrin. In order to proceed further thrombin activates platelets, which provide a procoagulant surface for the coagulation factors. Thrombin will also activate the vital cofactors V and VIII that will assemble on the surface of activated platelets. Thrombin can also activate factor XI, which is important in a feedback mechanism.

In the final step, the propagation phase, the highly efficient tenase and prothrombinase complexes have been assembled on the membrane surface. This yields large amounts of thrombin at the site of injury that can cleave fibrinogen to insoluble fibrin. Factor XI activation by thrombin then activates factor IX, which leads to the formation of more tenase complexes. This ensures enough thrombin is formed, despite regulation of the initiating TF-FVIIa complex, thus ensuring formation of a stable fibrin clot. Factor XIII stabilizes the fibrin clot through crosslinking when activated by thrombin.

English: Gene expression pattern of the VWF gene. (Photo credit: Wikipedia)

Coagulation cascade (Photo credit: Wikipedia)

Fibrinolytic pathway

Fibrinolysis is the physiological breakdown of fibrin to limit and resolve blood clots. Fibrin is degraded primarily by the serine protease, plasmin, which circulates as plasminogen. In an auto-regulatory manner, fibrin serves as both the co-factor for the activation of plasminogen and the substrate for plasmin.

In the presence of fibrin, tissue plasminogen activator (tPA) cleaves plasminogen producing plasmin, which proteolyzes the fibrin. This reaction produces the protein fragment D-dimer, which is a useful marker of fibrinolysis, and a marker of thrombin activity because fibrin is cleaved from fibrinogen to fibrin.

Bleeding after Coronary Artery bypass Graft

Cardiac surgery with concomitant CPB can profoundly alter haemostasis, predisposing patients to major haemorrhagic complications and possibly early bypass conduit-related thrombotic events as well. Five to seven percent of patients lose more than 2 litres of blood within the first 24 hours after surgery, between 1% and 5% require re-operation for bleeding. Re-operation for bleeding increases hospital mortality 3 to 4 fold, substantially increases post-operative hospital stay and has a sizeable effect on health care costs. Nevertheless, re-exploration is a strong risk factor associated with increased operative mortality and morbidity, including sepsis, renal failure, respiratory failure and arrhythmias.

(Gábor Veres. New Drug Therapies Reduce Bleeding in Cardiac Surgery. Ph.D. Doctoral Dissertation. 2010. Semmelweis University)

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Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Health Law & Patient Safety, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Technology Transfer: Biotech and Pharmaceutical, Valves & Tools, tagged Aortic valve, Aviva Lev-Ari, Columbia University Medical Center, Edward Lifescience, Percutaneous aortic valve replacement, TAVR, Transcatheter Aortic Valve Implantation on September 3, 2012| 4 Comments »

Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis

Reporter: Aviva Lev-Ari, PhD, RN

Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis

Raj R. Makkar, M.D., Gregory P. Fontana, M.D., Hasan Jilaihawi, M.D., Samir Kapadia, M.D., Augusto D. Pichard, M.D., Pamela S. Douglas, M.D., Vinod H. Thourani, M.D., Vasilis C. Babaliaros, M.D., John G. Webb, M.D., Howard C. Herrmann, M.D., Joseph E. Bavaria, M.D., Susheel Kodali, M.D., David L. Brown, M.D., Bruce Bowers, M.D., Todd M. Dewey, M.D., Lars G. Svensson, M.D., Ph.D., Murat Tuzcu, M.D., Jeffrey W. Moses, M.D., Matthew R. Williams, M.D., Robert J. Siegel, M.D., Jodi J. Akin, M.S., William N. Anderson, Ph.D., Stuart Pocock, Ph.D., Craig R. Smith, M.D., and Martin B. Leon, M.D. for the PARTNER Trial Investigators

N Engl J Med 2012; 366:1696-1704 May 3, 2012

Background

Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known.

Methods

We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed.

Results

A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation.

Conclusions

Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)

Supported by Edwards Lifesciences.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMoa1202277) was published on March 26, 2012, and updated on August 30, 2012, at NEJM.org.

Source Information

From Cedars–Sinai Heart Institute, Los Angeles (R.R.M., H.J., R.J.S.); Lenox Hill Heart and Vascular Institute (G.P.F.) and Columbia University Medical Center and New York Presbyterian Hospital (S. Kodali, J.W.M., M.R.W., C.R.S., M.B.L.) — both in New York; Cleveland Clinic Foundation, Cleveland (S. Kapadia, L.G.S., M.T.); Washington Hospital Center, Washington, DC (A.D.P.); Duke University School of Medicine, Durham, NC (P.S.D.); Emory University School of Medicine, Atlanta (V.H.T., V.C.B.), University of British Columbia and St. Paul’s Hospital, Vancouver, Canada (J.G.W.); Hospital of the University of Pennsylvania, Philadelphia (H.C.H., J.E.B.); Baylor Healthcare System (D.L.B., B.B.) and Medical City Dallas (T.M.D.) — both in Dallas; Edwards Lifesciences, Irvine, CA (J.J.A., W.N.A.); and London School of Hygiene and Tropical Medicine, London (S.P.).

Address reprint requests to Dr. Leon at Columbia University Medical Center, Center for Interventional Vascular Therapy, 161 Fort Washington Ave., 6th Fl., New York, NY 10032, or at mleon@crf.org.

The investigators, institutions, and research organizations participating in the Placement of Aortic Transcatheter Valves (PARTNERS) trial are listed in the Supplementary Appendix, available at NEJM.org.

http://www.nejm.org/doi/full/10.1056/nejmoa1202277

Contribution of Leg compressions to Recovery after a Stroke

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Biomarkers & Medical Diagnostics, Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Stents & Tools, tagged Clinical trial, Food and Drug Administration, Georgia Health Sciences University, health, Heart disease, Lancet, pharmaceutical intelligence, pharmaceuticalintelligence, Stroke, Tissue plasminogen activator on August 28, 2012| 3 Comments »

Reported by: Dr. Venkat S Karra, Ph.D.

Leg compressions may enhance stroke recovery:

Successive, vigorous bouts of leg compression s following a stroke appear to trigger natural protective mechanisms that reduce damage. Make use of the blood pressure cuff in the emergencies for the same.

Compressing then releasing the leg for several five-minute intervals used in conjunction with the clot-buster tPA, essentially doubles efficacy, said Dr. David Hess, a stroke specialist who chairs the Medical College of Georgia Department of Neurology at Georgia Health Sciences University. “This is potentially a very cheap, usable and safe – other than the temporary discomfort – therapy for stroke,” said Hess, an author of the study in the journal Stroke. The compressions can be administered with a blood pressure cuff in the emergency room during preparation for tPA, or tissue plasminogen activator, currently the only Food and Drug Administration-approved stroke therapy.

“Much like preparation to run a marathon, you are getting yourself ready, you are conditioning your body to survive a stroke,” Hess said of a technique that could also be used in an ambulance or at a small, rural hospital. For the studies Dr. Nasrul Hoda, an MCG research scientist and the study’s corresponding author, developed an animal model with a clot in the internal carotid artery, the most common cause of stroke. The compression technique called remote ischemic perconditioning – “per” meaning “during” –reduced stroke size in the animals by 25.7 percent, slightly better than tPA’s results. Together, the therapies reduced stroke size by 50 percent and expanded the treatment window during which tPA is safe and effective.

Next steps include looking for biomarkers that will enable researchers to easily measure effectiveness in humans, Hess said. One marker may be increased blood flow to the brain, which occurred in the treated animals.

The first clinical trial likely will include putting a blood pressure cuff on the legs of a small number of stroke patients to see if the finding holds. The researchers also have plans to analyze the blood of healthy individuals, before and after compression, seeking mediators that stand out as clear markers of change. They also want to go back to the animal model to see if applying the technique after giving tPA works even better. Clinical evidence already suggests that remote ischemic perconditioning can aid heart attack recovery, including a 2010 study in the journal Lancet in which the technique, used in conjunction with angioplasty to intervene in a heart attack, reduced heart damage. Nature seems to support it as well since people who experience short periods of inadequate blood flow – angina in the case of heart disease and transient ischemic attacks in the brain – before having a major event tend to recover better than patients who have a full-blown stroke or heart attack out of the blue.

“Small episodes of ischemia seem to protect our organs – not just our brains – from major ischemia,” said Hess, although the researchers are just starting to learn why. Theories include that leg muscles, in response to the temporary loss of blood and oxygen, somehow stimulate nerves to protect the brain and/or that the muscles themselves release the protection.

They also suspect the vagus nerve, which delivers information to the brain about how other organs are doing and helps regulate inflammation, is a player.

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Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Mitral Valve: Repair and Replacement, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Stents & Tools, Valves & Tools, tagged CE mark, European Union, FDA, Food and Drug Administration, Health Technology Assessment, Medical device, United States on August 9, 2012| 1 Comment »

Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

Reporter: Aviva Lev-Ari, PhD, RN

Saptarshi Basu, M.P.A., and John C. Hassenplug, M.Sc.

N Engl J Med 2012; 367:485-488 August 9, 2012

The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European approval process.1 This contention is often used to support the argument that the Food and Drug Administration (FDA) should lower its standards for approving medical devices, since a slow approval process is delaying Americans’ access to innovative and lifesaving technology. But a review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets (Germany, France, Italy, and Britain)2 — largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.

To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.

Second, an accurate comparison of time to market access requires measurement of the total time that elapses between application submission and market access. Previous studies have compared the chronologic dates of application submission and market access, but the date an application is submitted varies from country to country.

Third, patient access should be equated with the availability of reimbursement rather than with device approval, because broad patient access to a new device doesn’t occur until reimbursement by a national or third-party payer is available. Previous comparisons of the U.S. and European systems have used the approval date to measure process duration, but innovative, high-risk devices don’t reach a market where most patients can benefit from them immediately after gaining regulatory approval, though they may be accessible to patients who can afford to pay out of pocket. Rather, there is a second level of review through which public or private insurers decide whether and at what price they will pay for a device. Generally, public systems take longer than private insurers to make reimbursement decisions, and significantly more Europeans than Americans have public insurance. Two thirds of the U.S. population is covered by private health insurance, whereas only a fifth receives publicly funded reimbursement, primarily administered by the Centers for Medicare and Medicaid Services (CMS).

For both private and public systems in the United States, the pathway to patient access to a device starts with the submission of an application to the FDA. The FDA reviews innovative, high-risk devices for safety and effectiveness (clinical benefit) under the premarket approval (PMA) process, and information on the duration of reviews is publicly available. In fiscal year 2011, the FDA approved 40 applications for PMA. The average review time was 13.1 months, with 8.4 months attributed to FDA review time, and 4.7 months to the time the agency waits for the sponsor to address deficiencies in the application (“sponsor time”).3 CMS provides reimbursement for the majority of devices when they earn FDA approval. For a limited number of devices each year, however, CMS conducts a national coverage determination in response to external requests for validation or for devices that have limited or conflicting evidence of clinical benefit. This process averaged 8.6 months over the past 5 fiscal years.4 Although it is difficult to obtain data on how long private insurers take to make coverage decisions, anecdotal information from private insurers suggests that decisions are made within a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.

In Europe, by contrast, most of the 27 member countries of the European Union (EU) have publicly financed health care systems; such systems cover approximately four fifths of the populations of the four largest device markets. All EU countries require devices to first obtain a Conformité Européenne (CE) marking, which refers to a symbol shown on products that indicates market approval throughout the EU. The CE marking process is conducted by for-profit, third-party “notified bodies” that have been accredited by a member country to assess device safety and performance but do not evaluate effectiveness (which requires more clinical data). Although publicly available data are limited, anecdotal information from notified bodies suggests that the process takes 1 to 3 months, excluding sponsor time.

Most European patients do not have access to innovative, high-risk devices as soon as the devices receive a CE marking. Each country must first make a decision about reimbursement, a process that varies substantially among countries.5 Though a CE marking can be granted on the basis of fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those that the FDA imposes for device approval. European countries may require additional data on the device’s safety and effectiveness, as well as on cost-effectiveness.

In France, a centralized body makes reimbursement decisions after assessing the safety and effectiveness of individual devices. Reimbursement decisions in Italy are devolved to the various regions, and Britain and Germany conduct broader assessments of device types or procedures, rather than of individual devices. Typically, innovative devices not covered under an existing diagnosis-related group (DRG) require review under the lengthier Health Technology Assessment process, which assesses safety, clinical benefit, and cost-effectiveness. Government-provided information on time to reimbursement varies by country. Estimated time frames are an average of 71.3 months in Germany, a range of 36.0 to 48.0 months in France, a range of 16.4 to 26.3 months in Italy, and an estimated 18 months in Britain.

Using this information, we determined that the time it takes to bring innovative, high-risk devices to patients in the United States is similar to or shorter than that in the top four European markets (seefigure Comparison of Time to Market in Premarket Approval and Reimbursement Processes.). The public (CMS) process in the United States takes approximately as long as those in Italy and Britain, approximately half as long as that in France, and less than a third as long as that in Germany. The difference in time to market access is even greater when it comes to private insurers (covering the majority of the U.S. population), which often make reimbursement decisions within a few months after FDA approval.

To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see table Comparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.). These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.

These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than in another and do not reflect experiences with all innovative, high-risk devices. However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on August 1, 2012, at NEJM.org.

SOURCE INFORMATION

From the Office of Planning, Office of the Commissioner, Food and Drug Administration, White Oak, MD.

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Updated Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

Reporter: Aviva Lev-Ari, PhD,RN

UPDATED on 5/27/2014

Survival After TAVI: Longest Follow-up Data Yet Yield Some Surprises

Shelley Wood

May 23, 2014

Transcatheter Technologies Completes Durability Testing of Its Prosthetic Aortic Heart Valve, Intrinsic to World’s First ‘Truly Repositionable’ TAVI Device, TRINITY

January 28, 2014 6:29 AM

Business Wire

“This 3rd-generation TRINITY technology could be a game-changer for TAVI.” Prof. Dr. Christian Hengstenberg, MD, German Heart Center, Munich (Note: Prof. Dr. med Hengstenberg has no financial ties to Transcatheter Technologies.)

REGENSBURG, Germany–(BUSINESS WIRE)–January 28, 2014–

Transcatheter Technologies GmbH, an emerging medical device company that is developing a third-generation transcatheter aortic valve implantation (TAVI) system-TRINITY-announced today that an independent laboratory has completed ‘advanced wear testing’ (AWT) of the company’s TRINITY valve prosthesis, far exceeding minimum testing standards. Indeed, AWT of the TRINITY heart valve has already completed 600 million cycles, or an estimated 15 years of durability testing.

Transcatheter Technologies has previously announced the successful 30-day follow-up results of a pilot study of its TRINITY TAVI system that is designed to be the world’s first ‘truly repositionable’ and, therefore, best TAVI system.

“Unlike second-generation TAVI systems, the Trinity aortic valve is designed to be positioned precisely or repositioned, even after full implantation, in a safe and simple manner,” said principal investigator Prof. Dr. Christian Hengstenberg, a cardiologist at the German Heart Center, Munich, Germany, with no financial interest or arrangement or affiliation with Transcatheter Technologies. “In our study, Trinity’s novel sealing cuff continues to provide outstanding follow-up results without PVL (paravalvular leak), a frequent complication of TAVI. Equally important, the TRINITY aortic valve is designed to reduce the risk of atrio-ventricular (AV) block significantly through supra-annular positioning of the TRINITY valve.”

“We are extremely pleased that our TRINITY valve has already demonstrated three times the minimum standard for advanced wear testing of a tissue heart valve,” said Wolfgang Goetz, M.D., Ph.D., CEO, a cardiac surgeon by training. We also are extremely pleased with the continuing excellent results of our third-generation TRINITY System in the follow-up of our first patient.

“The big issue with the second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. TRINITY, however, is designed to solve this critically important issue and thereby potentially reduce the undesirable side consequences of PVL,” added Dr. Goetz. “With TRINITY, once our valve is completely expanded and anchored above the annulus, a cardiologist can fully evaluate the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position. This feature and its supra-annular anchoring are absolutely unique to TRINITY, which is why we have positioned TRINITY as a Third-Generation TAVI System.”

CAUTION: TRINITY is not approved for use in the United States

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

SOURCE

http://venturebeat.com/2014/01/28/transcatheter-technologies-completes-durability-testing-of-its-prosthetic-aortic-heart-valve-intrinsic-to-worlds-first-truly-repositionable-tavi-device-trinity/

Transcatheter aortic valve implantation (TAVI): risk for stroke and suitability for surgery

For additional discussion go to

Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

http://pharmaceuticalintelligence.com/2012/08/02/transcatheter-aortic-valve-implantation-tavi-risky-and-costly/

BMJ 2012; 345 doi: 10.1136/bmj.e4710 (Published 31 July 2012) Cite this as: BMJ 2012;345:e4710

Evidence for TAVI Questioned

By Chris Kaiser, Cardiology Editor, MedPage Today

Published: July 31, 2012

http://www.medpagetoday.com/Cardiology/PCI/33997

The tens of thousands of transcatheter aortic valve implantations (TAVI) performed worldwide may not have solid evidence behind them, European researchers suggested.

To begin with, a health technology assessment commissioned by the Belgian government suggested that only patients who are “deemed inoperable for technical reasons such as a series of previous operations or irradiation of the chest wall” be reimbursed for TAVI, according to Mattias Neyt, PhD, of the Belgian Health Care Knowledge Centre in Brussels, and colleagues.

That’s about 10% of patients currently being considered for the procedure, they wrote online in an analysis article in BMJ.

Why is there such a big disconnect between the growing number of patients undergoing TAVI and the findings of the Belgian technology assessment? Neyt and colleagues said there are several factors that have resulted in more enthusiasm than evidence for TAVI.

One of those factors is the process by which medical devices receive marketing approval in the E.U., which, they said, puts medical devices “on the same footing as domestic appliances such as toasters.”

As a consequence of what the authors referred to as “Europe’s lax licensing laws,” the two TAVI devices in common use today – Medtronic’s CoreValve and Edward Lifescience’s Sapien – were approved in 2007, “long before any substantial clinical trial evidence was available.”

Even the U.K.’s National Institute for Health and Clinical Excellence (NICE) concluded that the evidence was “adequate from a clinical point of view” for the use of TAVI in those unsuitable for surgery, but when surgery is an option — even a high-risk one — the evidence for TAVI was inadequate.

However, the British analysis did not consider costs associated with the procedure, Neyt and colleagues pointed out.

In the U.S., the FDA approval process is more rigorous than that of the E.U., but Neyt and colleagues were “far from convinced” that the results from the PARTNER trials (Cohort A andCohort B) were adequate to justify approval of the Sapien valve.

Although the cost-effectiveness of TAVI for inoperable patients (cohort B) is “equivocal,” they wrote, the clinical evidence seems to suggest that TAVI can be justified. However, they pointed out some problems that they said were not considered within the overall evidence, such as a higher rate of comorbidities and a higher rate of previous MIs among the inoperable control patients.

In PARTNER cohort A, where TAVI was compared with high-risk surgical patients, the authors noted a concern for a higher rate of stroke or transient ischemic attack among the TAVI patients.

Nevertheless, an FDA panel in June recommended expanding the indication for the Sapien valve to include high-risk surgical candidates. One of the panelists said that stroke is “just an accepted risk of the procedure.”

But Neyt and colleagues don’t accept that. They concluded that based on the evidence, as well as the concern for efficient use of limited resources, “it is difficult to see how healthcare payers can justify reimbursing TAVI for patients suitable for surgery, given that the risk of stroke is twice as high after TAVI.”

Another issue that could undermine the integrity of the evidence, Neyt and colleagues said, was the absence of full disclosure on the part of principal investigator Martin B. Leon, MD, from Columbia University.

According to the Belgian researchers, part of the deal involving the sale of Leon’s valve company to Edwards included future payments from Edwards “on the achievement of three milestones: successful treatment of 50 patients, regulatory approval in Europe, and limited approval in the U.S.”

These three milestones were not disclosed in the original paper published in the New England Journal of Medicine, they said.

Neyt and colleagues also complained that the FDA and Edwards Lifesciences are holding on to negative findings from an FDA-authorized follow-on study of 90 inoperable patients. Some of the data released at an FDA meeting in 2011 showed a higher 1-year mortality rate among those receiving TAVI (34.3% versus 21.6%), they said, but efforts to obtain any of those data have been rebuffed by both the FDA and Edwards.

They brought this concern to the editors of the NEJM, but the editors didn’t think the concern invalidated the overall PARTNER findings.

Tying all this together, Neyt and colleagues called for “a major improvement in transparency of information” that would “allow clinicians to practice evidence-based medicine, patients to make informed decisions, and health technology assessment agencies to make the right judgments.”

The authors reported they had no relationships to disclose.

Primary source: BMJ

Source reference:
Van Brabandt H, et al “Transcatheter aortic valve implantation (TAVI): risky and costly” BMJ 2012; 345: e4710.

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Transcatheter Aortic Valve Implantation (TAVI): FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, Pharmacotherapy of Cardiovascular Disease, Valves & Tools, tagged Aortic valve replacement, Belgium, Edwards Lifesciences, Edwards Lifesciences Corporation, Food and Drug Administration, medicine, TAVI on August 2, 2012| 10 Comments »

Transcatheter Aortic Valve Implantation (TAVI): FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED ON 8/23/2016

FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery

about a third of patients referred for open-heart surgery for aortic-valve replacement fall into the intermediate-risk category, defined as having at least a 3% risk of death within 30 days of surgery.

http://www.medscape.com/viewarticle/867656?nlid=109007_3866&src=WNL_mdplsfeat_160823_mscpedit_card&uac=93761AJ&spon=2&impID=1183827&faf=1

For Immediate Release

August 18, 2016

Release

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.

“This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.”

Aortic valve stenosis increases with age as the aortic valve becomes narrow, causing the heart to work harder to pump enough blood through a smaller opening. It occurs in about three percent of Americans over age 75 and can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to have a heart valve replacement to improve blood flow through their aortic valve.

Traditionally, open-heart surgery has been the gold standard for aortic valve replacement in intermediate risk patients, but it involves a larger incision and longer recovery time than the minimally invasive procedure used to insert the transcatheter heart valve. About one-third of patients referred for open-heart surgery for aortic valve replacement fall into the “intermediate risk” category, which is defined as having a greater than three percent risk of dying within 30 days following surgery.

In a clinical study to evaluate safety and effectiveness, 1,011 aortic stenosis patients at intermediate risk for surgical complications were randomly selected to have a transcatheter aortic valve replacement procedure using the Sapien XT valve and 1,021 were randomly selected to have a traditional aortic valve replacement during open-heart surgery using a surgical tissue valve. In a second study, 1,078 intermediate risk patients were implanted with the Sapien 3 valve; and outcomes in these patients were compared to the same group of 1,021 surgical control patients in the first study. The two studies demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and Sapien 3 devices in intermediate risk patients.

Patients who receive either the Sapien XT or the Sapien 3 valve face a potential risk of serious complications from the device or implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.

The devices are contraindicated for patients who cannot tolerate blood thinning medication. They are also contraindicated for those who are currently being treated for a bacterial or other infection.

As part of the approval of these devices, the FDA is requiring the manufacturer to conduct a post-approval study to follow the patients treated with either device in the first and second clinical studies for 10 years to further monitor safety and effectiveness.

Sapien XT and Sapien 3 are manufactured by Edwards Lifesciences, LLC, based in Irvine, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Related Information

SOURCE

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517281.htm

8/2/2012

Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

On this Scientific Web Site, Frontiers in Cardiology and Cardiac Repair are reported as discovered and debated in the literature. Our address of the innovations involving the development of TAVI are reported as follows:

June 4, 2012 — Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment http://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

June 10, 2012 — Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment http://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

June 19, 2012 — The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) http://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

June 19, 2012 — Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market http://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

Our reporting on Regulatory Affairs for Medical Devices was reported on 7/31/2012.

July 31, 2012 — Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice http://pharmaceuticalintelligence.com/2012/07/31/gaps-tensions-and-conflicts-in-the-fda-approval-process-implications-for-clinical-practice/

On August 1, 2012, in BJM researchers at KCE, Belgian Health Care Knowledge Centre, Administratief Centrum Kruidtuin, Kruidtuinlaan 55, 1000 Brussels, Belgium; 2CEBAM, Belgian Centre for Evidence-Based Medicine and Branch of the Dutch Cochrane Centre, Leuven, Belgium — reported research results which are examining why the practice of TAVI has gone beyond the evidence.

Edwards Lifesciences shares closed down more than 2% yesterday after the British Medical Journal said many procedures using its Sapien heart valve “cannot be justified on medical or cost-effectiveness grounds.”

On August 1, 2012 — Shares of Edwards Lifesciences (NYSE:EW) slid 2.2% yesterday after an analysis published in the British Medical Journal claimed that “many” of the heart valve replacements using its flagship Sapien heart valve “cannot be justified” and leveled accusations of conflict of interest and unethical conduct against Edwards and Sapien inventor Dr. Martin Leon.

http://www.massdevice.com/news/edwards-lifesciences-slides-rebounds-negative-heart-valve-study

A trio of Belgian researchers said their “rigorous analysis of all the available data, in combination with a study of real world [transcatheter aortic valve implant] practice in Europe, led us to conclude that the arguments supporting the widespread use of TAVI do not stand up to scrutiny.”

“In addition, the Partner trial seems to have important problems, the most relevant being publication bias and lack of data transparency, unbalanced patient characteristics, and incompletely declared conflicts of interest,” wrote Hans Van Brabandt, Mattias Neyt and Frank Hulstaert, who were commissioned by the Belgian government to run the analysis.

Edwards shares closed on 8/1/2012 at $101.20, down 2.2%,

On 8/2/2012 it closed at 99.30 (0.75 below yesterday)

52wk Range:	61.59 – 106.94

The BMJ researchers wrote that Belgian health authorities should pay for only about 10% of the patients now considered for trancatheter aortic valve replacements in the lowland country – procedures using the Sapien heart valve and a competing device, Medtronic‘s (NYSE:MDT) CoreValve implant, should be limited to patients who aren’t good candidates for traditional open heart surgery. The CoreValve device is not yet approved for the U.S. market.

Edwards’ Partner trial for the Sapien valve was flawed due to potential bias on the part of Leon, according to the researchers. Leon founded a company to develop the implant that Edwards acquired in 2004, triggering a $6.9 million payout that was disclosed. But other milestone payments due to Leon were not disclosed, they wrote, creating “substantial financial interests that we do not believe were fully disclosed.””We believe Dr. Marty Leon has conducted himself throughout the Partner trial in accordance with the highest ethical standards. In his role as co-principal investigator of the trial, he has only been reimbursed for travel-related expenses,” an Edwards spokeswoman told MassDevice.com in an email today. “Dr. Leon also has – throughout the Partner trial – remained in compliance with the strict conflict-of-interest standards of both the FDA and Columbia University. As previously reported, the sale of PVT to Edwards took place in 2004 and the single milestone payment (that Dr. Leon donated to charity) was made in 2006, well before the beginning of the pivotal trial.”The Partner study was also biased by imbalance between the treatment and control groups in the TAVI cohort that favored Sapien, they wrote.Brabandt, Neyt and Hulstaert also claimed that repeated requests to Edwards and Leon for access to data from an FDA-ordered follow-on study of the Sapien device “went unanswered.”

“In our view, this behaviour is both ethically and scientifically unacceptable and should be legally regulated in
future [sic],” they wrote. “Study sponsors should be obliged to make the results of a negative trial public so that policy makers can reach rational and balanced decisions.”

Some of that data, from a 90-patient study of inoperable candidates, was presented at an FDA meeting in July 2011, according to the Belgian researchers. Those results demonstrated a higher risk of mortality after a year among the cohort treated with the Sapien valve (34.3% vs. 21.6%, they wrote).

The researchers also took a shot at the New England Journal of Medicine, which they approached after being rebuffed by Edwards and Leon. The NEJM editors passed the researchers’ “objections” on to the investigators, but the response convinced the editors that “while each of the points we raised deserved a thoughtful review, they did not, either individually or together, fundamentally place the findings of the Partner trial in serious doubt.”

“NEJM has, however, published 2-year follow-up results that essentially confirmed the one year data. However, it did so without demanding that the study sponsor publish or discuss the negative results of the follow-on trial. It is difficult to understand this decision,” the Belgian researchers wrote.

“Based on current evidence, and considering efficient use of limited resources, it is difficult to see how healthcare payers can justify reimbursing TAVI for patients suitable for surgery, given that the risk of stroke is twice as high after TAVI,” the researches concluded. “In addition, TAVI is much more expensive, on average about €20,000 more per patient in our analysis of Belgian data. Based on observational data, the costs during the initial hospital admission, inclusive of an Edwards Sapien valve of €18,000, are on average €43,600 for TAVI versus €23,700 for surgical valve replacement.”

Transcatheter aortic valve implantation (TAVI): risky and costly

Many of the 40 000 transcatheter procedures so far carried out cannot be justified on medical or cost effectiveness grounds. Hans Van Brabandt, Mattias Neyt, and Frank Hulstaert examine why practice has gone beyond the evidence. The three researchers are:

Hans Van Brabandt researcher 1 2, Mattias Neyt researcher 1, Frank Hulstaert researcher 1

1KCE, Belgian Health Care Knowledge Centre, Administratief Centrum Kruidtuin, Kruidtuinlaan 55, 1000 Brussels, Belgium; 2CEBAM, Belgian Centre for Evidence-Based Medicine and Branch of the Dutch Cochrane Centre, Leuven, Belgium

Correspondence to: M Neyt mattias.neyt@kce.fgov.be

BMJ 2012;345:e4710 doi: 10.1136/bmj.e4710 (Published 31 July 2012) Page 1 of 5

Analysis

Around the world, tens of thousands of people have been treated for a life threatening heart condition using a minimally invasive technique that many see as the wave of the future. Transcatheter aortic valve implantation (TAVI) offers hope to patients too old or too ill for conventional aortic valve replacement operations, and since its introduction 10 years ago it has spread swiftly—by the end of 2011, an estimated 40 000 transcatheter implantations had been done.1 But serious unanswered questions remain over the clinical outcomes and the cost effectiveness of TAVI, as well as the regulatory process that enabled it to gain such a large market so rapidly, particularly in Europe.

Aortic stenosis, the progressive failure of the aortic valve to open fully, is the commonest type of valve disease in elderly people. It is usually treated by valve replacement surgery, but around a third of those who might benefit are turned down because the risks of surgery are too high or because problems such as a calcified aorta or scarring from previous surgery make them unsuitable for surgery.2 Untreated, most will die within five years.3 TAVI offers an alternative, in which a replacement valve is introduced through an artery via a small incision (usually the femoral artery) or, less often, surgically with an incision into the chest and then into the left ventricular apex—the transapical approach.

The numbers who could potentially benefit from TAVI are verylarge.4 Almost 3% of people over 75 have aortic valve disease,5which means that in England alone there are more than 100 000patients in whom aortic valve surgery might at a given moment be contemplated. But only around 1200 aortic valve replacements are carried out in this age group in England each year. This helps explain the enthusiasm with which TAVI has been taken up, and the large potential market. In April 2011, a New York securities analyst for the financial services company Wells Fargo estimated that TAVI could generate more than $2.4bn (£1.5bn; €2bn) in sales in the US and account for more than a third of aortic valve replacements by 2015.6 Cardiologists in the US also expect growing demand from patients who are suitable for conventional surgery but who prefer the quicker and less painful transcatheter option. Data reported at the European Society of Cardiology (EuroPCR) meeting in Paris in May7 suggested that transcatheter procedures have more than tripled in Europe since 2009, rising to 18 372 in 2011. Germany is far ahead of other European nations, being responsible for 43% of all TAVIs, followed by France (13%), Italy (10%), and the UK and Ireland (7%).1

Approval processes

Given the enthusiasm with which the procedure has been adopted, we might expect the evidence for its efficacy to be solid. But a health technology assessment we carried out, commissioned by the Belgian government, concluded that the Belgian health authorities should pay for TAVI in only a minority of patients (10%) of those currently considered for treatment—those who are deemed inoperable for technical reasons such as a series of previous operations or irradiation of the chest wall.8 The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) guidance issued in March this year said that for patients considered unsuitable for surgery, the evidence for TAVI was adequate from a clinical point of view but it did not take costs into account.9 But NICE said that for patients for whom surgery is suitable, albeit risky, the evidence for using TAVI was inadequate, and it should be used in these circumstances only when special arrangements for clinical governance, consent, and data collection or research were in place.9

In the European Union, medical devices fall outside the scope of the European Medicines Agency and need only a simple quality certificate (CE mark) to gain access to the market, putting them on the same footing as domestic appliances such as toasters. Two different valves for transcatheter implantation gained their CE marks in 2007, long before any substantial clinical trial evidence was available: the Edwards Sapien valve and the Medtronics CoreValve. In the US the law demands evidence of efficacy in a randomised trial before the Food and Drug Administration can license any innovative device. Thus TAVI was in use in Europe four years before the FDA licensed the Sapien valve in November 2011, and—in contrast to Europe—only for the transfemoral approach and for patients considered unsuitable for standard valve surgery.10 The transapical route was not approved. In June 2012, a panel of expert advisers recommended that the FDA approved the Sapien valve for high risk operable patients, including a transapical delivery option.11 The advisory panel does not take economic considerations into account.

The European system for approving medical devices has already come in for criticism over breast and hip implants, with the new executive director of the EMA, Guido Rasi, acknowledging in January that there is an urgent need to regulate devices with the same care as medicines. “I think, at the end of the day, we will see everyone moving to increasing use of comparative trials,” Rasi said in an interview with Reuters.12 He expected that concerns about the now defunct French breast implant company Poly Implant Prosthese might help to speed the process. But while the evidence demanded by the FDA exceeded that required in Europe, we remain far from convinced that it is adequate. The Sapien valve was approved on the basis of a trial called PARTNER (Placement of Aortic Transcatheter Valve).

We reviewed the conduct and results of the trial through papers published in peer reviewed journals, proceedings from congresses, press releases, and direct contacts with the manufacturer, the FDA, the New England Journal of Medicine (NEJM) (where it was published), and the principal investigators.

Our rigorous analysis of all the available data, in combination with a study of real world TAVI practice in Europe, led us to conclude that the arguments supporting the widespread use of TAVI do not stand up to scrutiny. In addition, the PARTNER trial seems to have important problems, the most relevant being publication bias and lack of data transparency, unbalanced patient characteristics, and incompletely declared conflicts of interest.

What the evidence shows

PARTNER was a randomised controlled trial in 26 sites, most of them in the US. It allocated patients with severe aortic valve stenosis to two groups: those at very high risk from surgery (cohort A)13 and those deemed inoperable (cohort B).14 The 699 patients in cohort A were randomised either to TAVI or to surgical valve replacement, and the 358 in cohort B were randomised to TAVI or standard therapy, which was balloon aortic valvuloplasty in most cases, combined with medical supportive treatment.

The results showed that in the high risk operable patients, mortality at one year was similar for TAVI and surgical insertion (24.2% v 26.8%, P=0.44) (table⇓). PARTNER was designed as a non-inferiority trial, with a difference of 7.5 percentage points in survival set as the margin, so TAVI met this target. But strokes and transient ischaemic attacks were significantly commoner in the TAVI group at one year (8.3% v 4.3%, P=0.04) and major vascular complications significantly commoner at 30 days (11.0% v 3.2%, P=0.001). Major bleeding and new onset atrial fibrillation were significantly higher in the surgical group. At one year, symptoms were about the same in both groups.13

In the patients deemed inoperable, results were relatively better. Mortality at one year was significantly lower for TAVI (30.7% v 50.7%, P<0.001). Again, however, there was a higher incidence of stroke and major vascular events in the TAVI group (10.6% v 4.5%, P=0.04).14 Taken together, these results suggest that TAVI can be justified for inoperable patients on clinical grounds, though cost effectiveness calculations are more equivocal. But even this conclusion is thrown into doubt by a follow-up study authorised by the FDA, in which 41 inoperable patients were randomised to TAVI and 49 to standard therapy. This study remains unpublished, and our attempts to gain access to further details have been rebuffed by the FDA and the study sponsor. But the data presented at an FDA meeting on 20 July 2011 showed that the TAVI patients fared worse than those given standard therapy (one year mortality 34.3% v 21.6%).15

We have repeatedly sought access to further details of this follow-on trial, carried out under FDA auspices as a formally approved “continued access study,” the purpose of which is to enable sponsors of clinical investigations to continue to enroll patients while a market application is being sought. The FDA responded that any further data analysis of a premarket application is proprietary information and that it was up to the sponsor to release it, if so inclined. But our requests to the sponsor (Edwards) and the principal investigator went unanswered. In our view, this behaviour is both ethically and scientifically unacceptable and should be legally regulated in future. Study sponsors should be obliged to make the results of a negative trial public so that policy makers can reach rational and balanced decisions.

Given our failure to make progress with the FDA or the sponsor, we approached the NEJM which had published the PARTNER trial. We put our objections to the NEJM, which passed them on to the investigators. Their response convinced the NEJM editors that “while each of the points we raised deserved a thoughtful review, they did not, either individually or together, fundamentally place the findings of the PARTNER trial in serious doubt.” Asked what the responses of the investigators had been, NEJM responded that it had not requested permission from them to pass them on, since they were intended for its own confidential evaluation. We were recommended to request this information directly from the study sponsor, which we did, to no avail.

NEJM has, however, published two year follow-up results that essentially confirmed the one year data.16 17 However, it did so without demanding that the study sponsor publish or discuss the negative results of the follow-on trial. It is difficult to understand this decision. Our concerns about the PARTNER trial go further than this, however. Published data on the inoperable patients, who had the most convincing results, show that the treatment and control groups are unbalanced in a way that would favour TAVI. The control group contained more patients with comorbidities, more who had had a previous heart attack, and more who were classified as frail than the TAVI group. There were fewer patients with an extensively calcified aorta. All these differences could have arisen from a flawed randomisation or by chance; but since they favour TAVI, an analysis that adjusted for prognosis at baseline would have produced a more realistic estimate of the effect size.

Disclosure of interests

BMJ 2012;345:e4710 doi: 10.1136/bmj.e4710 (Published 31 July 2012) Page 1 of 5

Practice beyond the evidence

What concerns us most is that in Europe the use of TAVI in the transapical route far exceeds what is justified by the clinical evidence. The PARTNER trial does not provide clear evidence on this route. A subgroup analysis suggests that the transapical approach is not inferior to surgery but has double the risk of stroke. Although the FDA proposed it,19 the trial sponsor declined to include a transapical arm in inoperable patients. But despite this dearth of evidence, TAVI is widely used transapically in Europe.

The UK TAVI registry, for example, shows that 409 of 1620 TAVI patients (25%) were treated transapically, with a one year mortality of 25.5%.20 The FRANCE-2 registry shows that of 2430 patients treated in 2010 and 2011, 20% had transapical TAVI, with a six month mortality of 20.2%.21 We cannot know, of course, what the survival rate of these patients would have been if they had been treated medically or by standard surgery. A position statement by the British Cardiovascular Intervention Society and the Society of Cardiothoracic Surgeons does not distinguish between the transfemoral and transapical approaches despite the different evidence bases.22 It states that TAVI should currently be reserved for patients in whom “the risk/benefit ratio of open heart surgery versus TAVI favours TAVI.” It calls for randomised trials, but only when centres in the UK have got “beyond their learning curve.” Patients may be surprised to hear that trials are being delayed to allow cardiologists and surgeons time to learn the technique.

Concerns about transapical TAVI were heightened by the early termination of a Danish trial called STACCATO,23 which compared transapical TAVI against conventional surgery. Five of 34 TAVI patients and only one of 36 surgically treated patients had either died or had a major stroke or renal failure within 30 days, prompting the data safety monitoring board to call a halt. This discouraging result was reported at the 2011 transcatheter cardiovascular therapeutics conference in San Francisco and drew criticism from Michael Mack, of the University of Texas at Dallas, who said the study was poorly designed and poorly executed.24 Mack, an investigator in the PARTNER trial, said: “I think there is some misinformation here, based on an invalid trial design, that is likely to hurt the field.”

Leif Thuesen, of Aarhus University Hospital in Denmark, who presented the STACCATO results, was more concerned with patients than with the field. “There is no doubt that there are patients who can’t be operated on, and they should be treated with TAVI” he told heartwire. “But the patient who can be operated on—here, we should be very, very cautious. It’s the operable patients, the low-risk patients, they should not have the TAVI procedures, but that’s what is happening. We had one patient, for instance, who did not want the conventional operation, so he had the TAVI procedure in Canada. That’s how it is. Indications are slipping.”24 In contrast to the current situation in Europe, we recommend that marketing approval for a high risk device should be granted for specific indications only. Each of these indications should be supported by clinical evidence from high quality randomised trials. Patients may be at risk if the high risk device is routinely used outside those indications. Payers may have an interest in limiting reimbursement of such high risk devices only to those indications for which there is a high level of evidence of efficacy and cost effectiveness.25

Based on current evidence, and considering efficient use of limited resources, it is difficult to see how healthcare payers can justify reimbursing TAVI for patients suitable for surgery, given that the risk of stroke is twice as high after TAVI. In addition, TAVI is much more expensive, on average about €20,000 more per patient in our analysis of Belgian data. Based on observational data, the costs during the initial hospital admission, inclusive of an Edwards Sapien valve of €18 000, are on average €43 600 for TAVI versus €23 700 for surgical valve replacement. The average cost of transapical TAVI is higher than for the transfemoral approach (€49 800 v €40 900).26 The NICE guidance did not include a cost-benefit analysis, but these costs should be taken into account by local NHS commissioners in decisions about whether to fund the procedure. If policy makers are willing to pay for TAVI, they should give priority to anatomically inoperable patients.8 26 Europe’s lax licensing laws set up in an era where medical devices typically comprised hearing aids, walking frames, and spectacles are not appropriate for implantable devices. It should require high quality randomised trials to show clinical efficacy and safety before granting marketing approval to innovative, high risk medical devices. And a major improvement in transparency of information is also needed to allow clinicians to practise evidence based medicine, patients to make informed decisions, and health technology assessment agencies to make the right judgments.

REFERENCE

1 Nainggolan L. Germany tops TAVI table, but room for growth remains, 1 November, 2011. www.theheart.org/coverages.do.

2 Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 2005;26:2714-20.

3 Varadarajan P, Kapoor N, Bansal RC, Pai RG. Survival in elderly patients with severe aortic stenosis is dramatically improved by aortic valve replacement: results from a cohort of 277 patients aged ≥80 years. Eur J Cardiothorac Surg 2006;30:722-7.

4 Ray S. Estimated population need for TAVI, data presented at a consensus meeting, 16 December 2008. www.ucl.ac.uk/nicor/audits/tavi/pdfs/estimated.

5 Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, et al. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol 1997;29:630-4.

6 Cortez M. Edwards valve study may spur patient demand doctors aren’t ready to meet Bloomberg News 2011 Apr 4. www.bloomberg.com/news/2011-04-04/edwards-valvestudy- may-spur-patient-demand-doctors-aren-t-ready-to-meet.html.

7 TAVI numbers rise in Europe as reimbursement, expertise expands. Heartwire 2012 May 17. www.theheart.org/article/1401795.do.

8 Neyt M, Van Brabandt H, Van de Sande S, Devriese S. Transcatheter aortic valve implantation (TAVI): a health technology assessment update. KCE reports 163C. Belgian Health Care Knowledge Centre (KCE), 2011.

9 NICE. Transcatheter aortic valve implantation for aortic stenosis. NICE interventional procedure guidance 421. NICE, 2012.

10 FDA. Edwards SAPIENTM transcatheter heart valve, model 9000TFX, sizes 23mm and 26mm and accessories. www.accessdata.fda.gov/cdrh_docs/pdf10/p100041a.pdf.

11 Wood S. Approve Sapien TAVR for high-risk operable patients, FDA advisors say. Heartwire 2012 Jun 14. www.theheart.org/article/1414539.do.

12 Hirschler B. EU medicines head urges tougher implant rules. 2012 www.reuters.com/ article/2012/01/06/us-breastimplants-ema-idUSTRE8050VL20120106.

13 Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-98.

14 Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607.

15 FDA. SAPIEN THV briefing document—advisory committee meeting. FDA, 2011:301.

16 Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366:1696-704.

17 Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686-95.

18 Medicine in conflict. Businessweek 2006 Oct 23. www.businessweek.com/magazine/ content/06_43/b4006081.htm.

19 FDA. FDA executive summary: Edwards SAPIEN THV. FDA, 2011.

20 Blackman D. Outcome of TAVI by valve type and access route: UK TAVI registry. 2011. www.pcronline.com/Lectures/2011/Outcome-of-TAVI-by-valve-type-and-access-route.- UK-TAVI-registry.

21 Gilard M. FRANCE II—French aortic national core valve and Edwards registry. EuroPCR conference, Paris, 17-20 May 2011.

22 British Cardiovascular Intervention Society, Society of Cardiothoracic Surgeons. Transcatheter aortic valve implantation (TAVI): a position statement. www.ucl.ac.uk/nicor/ audits/tavi/pdfs/bcisposition.

23 Nielsen HH, Klaaborg KE, Nissen H, Terp K, Mortensen PE, Kjeldsen BJ, et al. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention 2012. May 14. [Epub ahead of print].

24 O’Riordan M. STACCATO; transapical TAVI in surgery-eligible patients stopped due to adverse events. Heartwire 2011 Nov 10. www.theheart.org/article/1307437.do.

25 Hulstaert F, Neyt M, Vinck I, Stordeur S, Huić M, Sauerland S, et al. The pre-market clinical evaluation of innovative high-risk medical devices. KCE Report 158C. D/2011/10.273/31. Belgian Health Care Knowledge Centre, 2011.

26 Neyt M, Van Brabandt H, Devriese S, Van De Sande S. A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population. BMJ Open 2012;2:e001032.

Table

Table 1| One year mortality and stroke rate in the PARTNER trial13 14 15

Inoperable patients

High risk patients* Pivotal trial† Continued access study‡

TAVI AVR P value TAVI Control P value TAVI Control

No of patients 348 351 179 179 41 49

1 year all cause mortality (% (No of events))§ 24.2 (84) 26.8 (89) 0.44 30.7 (55) 50.7 (89) <0.001 34.3 (13) 21.6 (10)

1 year stroke rate (% (No of events))¶ 8.3 (27) 4.3 (13) 0.04 10.6 (19) 4.5 (8) 0.04 2.4 (1) 0 (0)

TAVI= transcatheter aortic valve implantation, AVR=surgical aortic valve replacement.

*Hazard ratio with TAVI in high risk patients: 0.93 (95% CI 0.71 to 1.22; P=0.62)

†Hazard ratio with TAVI in inoperable patients (pivotal trial): 0.55 (95% CI 0.40 to 0.74; P<0.001);

‡No P value or hazard ratio was published for the continued access study.

§ Kaplan-Meier estimates.

¶ Includes any stroke and transient ischaemic attack; stroke rate in continued access study includes “major stroke” only.

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Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Exec Compensation in the Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Mitral Valve: Repair and Replacement, Stents & Tools, Valves & Tools, tagged Aortic valve, Coronary stent, Edwards Lifesciences, Edwards Lifesciences Corporation, Industry Concentration Ratio in Medical Devices Markets, Market Penetration Cost, Market Penetration in Medical Devices Market, Niche supplier, Peripheral, Stent, Vascular surgery on June 22, 2012| 12 Comments »

Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders) in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Curator: Aviva Lev-Ari, PhD, RN

The ecosystem of Cardiac and Vascular Surgery for Repair or Replacement by Implantation of a new blood vessel or medical device covers the following procedure-related devices and tools now in use:

Arterial catheterization kit
Embolectomy catheters
Occlusion catheter
Coronary stents
Neurovascular stents
Carotid stents
External and internal carotid shunts
Peripheral stents
Biliary stents
Micro vascular clips
Stainless steel tunneler vascular graft
Cardiopulmonary bypass vascular catheter
Coronary stent graft system
Catheter tip occluder
Synthetic/biological composite vascular graft
Valvulotome tools
Aortic Valve
Mitral Valve
Angioplasty Guided Wires

No Aorta valve suppliers in MA. The National Leader supplier Edwards Lifesciences and its SAPIEN product for Transcatheter Aortic-Valve Implantation (TAVI) and Replacement (TAVR) is covered in Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market 6/20/2012

http://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

Medical Devices Market in Massachusetts: Product Concentration Ratios (1 to 10) by Product and Partnership Target Advantage – Niche Suppliers vs. National Leader in the Cardiology & Vascular Surgery Tools and Devices in use in Cardiac Operating Rooms and in Angioplasty Suites

Industry Concentration Ratios per Product Line in the Cardiac and Vascular Medical Devices Segments
A	B	C	D	E	F	G	H	I	J
		US comparison				MA comparison
Cardiology & Vascular Surgery Tools and Devices in use	Global Suppliers	US Suppliers	Market share	Global ratio	Index	MA Suppliers	Market share	Global ratio	Index
Arterial catheterization kit	4	6	0.09	0.40	5.6	2	0.14	0.67	3.6
Embolectomy catheters	11	28	0.03	0.28	1.9	3	0.07	0.79	2.4
Occlusion catheter	1	7	0.11	0.13	2.8	3	0.20	0.25	2.4
Coronary stents	11	34	0.02	0.24	1.7	2	0.07	0.85	2.6
Neurovascular stents	2	6	0.11	0.25	4.5	1	0.25	0.67	5.5
Carotid stents	1	12	0.07	0.08	1.7	1	0.33	0.50	5.5
External and internal carotid shunts	2	5	0.13	0.29	5.5	2	0.20	0.50	3.7
Peripheral stents	0	7	0.13	0.00	1.0	1	0.50	0.00	1.0
Biliary stents	7	13	0.05	0.35	3.1	1	0.11	0.88	3.6
Micro vascular clips	3	6	0.10	0.33	5.2	2	0.17	0.60	3.7
Stainless steel tunneler vascular graft	3	3	0.14	0.50	10.0	1	0.20	0.75	5.1
Cardiopulmonary bypass vascular catheter	14	39	0.02	0.26	1.6	5	0.05	0.74	2.0
Coronary stent graft system	0	6	0.14	0.00	1.0	1	0.50	0.00	1.0
Catheter tip occluder	1	6	0.13	0.14	3.3	2	0.25	0.33	3.3
Synthetic/biological composite vascular graft	3	5	0.11	0.38	6.3	2	0.17	0.60	3.7
Valvulotome tools	3	6	0.10	0.33	5.2	1	0.20	0.75	5.1
Aortic Valve	2	9	0.08	0.18	2.9	0	0.33	1.00	10.0
Mitral Valve	4	7	0.08	0.36	4.8	0	0.20	1.00	6.4
Angioplasty Guided Wires	8	11	0.05	0.42	3.7	2	0.09	0.80	3.0
					126				27
Source for A, B, C, G – http://www.medicregister.com
Source for D,E,F,H,I,J – Computed ratios per formulas below byAviva Lev-Ari, PhD, RN
D = 1/(1+B+C) = projected market share assuming non-differential production capacity

E = B/(B+C) = fraction of global among all suppliers

F = DE$F$24+1 = product of “D” and “E”, scaled to be in the range from 1 to 10

“H” is the same as “D” but with MA suppliers replacing “US suppliers”
“I” is the same as “E” but with MA suppliers replacing “US suppliers”
“J” is the same as “F” but with MA suppliers replacing “US suppliers”

Product Advantage for Partnership with Niche Suppliers in MA

Product Concentration Ratio (PRC) for Tools and Devices in use in Cardiology & Vascular Surgery	Targeting a Niche Supplier based in Massachusetts	Aiming at the Industry Leader
Arterial catheterization kitPRC = 3.6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Smiths Medical ASD, Inc Weston
External and internal carotid shuntsPRC = 3.7	Bard Electrophysiology www.bardep.comLowell Lemaitre Vascular, Inc. www.lemaitre.com Burlington
Micro vascular clipsPRC = 3.7	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Life Instrument Corporation www.lifeinstruments.com Braintree
Stainless steel tunneler vascular graftPRC = 5.1	Lemaitre Vascular, Inc. www.lemaitre.comBurlington
Cardiopulmonary bypass vascular catheterPRC = 2	Abiomed, Inc. www.abiomed.comDanvers Vortex Medical Inc www.angiovac.com Norwell Lemaitre Vascular, Inc. www.lemaitre.com Burlington Clinical Instruments Intl., Inc. Southbridge Smiths Medical ASD, Inc Weston
Coronary stent graft systemPRC = 2.6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington
Catheter tip occluderPRC = 2.4	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge
Valvulotome toolsPRC = 5.1	Lemaitre Vascular, Inc. www.lemaitre.comBurlington

Product Advantage for Partnership with National Leader in MA

Cardiology & Vascular Surgery Tools and Devices in use	Niche Supplier based in Massachusetts	Industry Leader
Neurovascular stentsPRC = 5.5		Boston Scientific Corporation www.bostonscientific.comNatick
Carotid stents PRC = 5.5		Boston Scientific Corporation www.bostonscientific.comNatick
Peripheral stentsPRC = 1		Boston Scientific Corporation www.bostonscientific.comNatick
Biliary stentsPRC = 3.6		Boston Scientific Corporation www.bostonscientific.comNatick

Product Advantage for Partnership with Niche Suppliers and National Leader in MA

Cardiology & Vascular Surgery Tools and Devices in use	Niche Supplier based in Massachusetts	Industry Leader
Embolectomy cathetersPRC = 2.4	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge	Boston Scientific Corporation www.bostonscientific.comNatick
Occlusion catheterPRC = 2.4	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Telemed Systems Inc. www.telemedsystems.com Hudson	Boston Scientific Corporation www.bostonscientific.comNatick
Coronary stentsPRC = 2.6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	Boston Scientific Corporation www.bostonscientific.comNatick
Synthetic/biological composite vascular graftPRC = 3.7	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	Boston Scientific Corporation www.bostonscientific.comNatick
Angioplasty Guided WiresPRC = 3.0	Arrow International, Walrus DivisionWoburn	Boston Scientific Corporation www.bostonscientific.comNatick

Source:

http://www.medicregister.com/Cardiology_Vascular_Surgery/Categories/cid2.htm

Penetration Strategy for a Global Supplier Targeting the US Market in Massachusetts

Customized predictions of penetration cost and estimation of potential revenues based on the industry segment concentration ratios in the Table above per Partnership Option are part of an Actionable Strategic Market Entry Plan in Massachusetts.

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Aviva Lev-Ari, PhD, RN

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Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, CABG, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Mitral Valve: Repair and Replacement, Pharmacotherapy of Cardiovascular Disease, Stents & Tools, Valves & Tools, tagged Angioplasty Suite, Cardiac & Vascular Repair, Cardiac Surgery Operating Room, Industry Concentration Ratio in Medical Devices Markets, Market Penetration Cost, Market Penetration in Medical Devices Market, National Leader Supplier, Niche supplier, Potential Revenue by Partnership Options on June 22, 2012| 20 Comments »

Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Curator: Aviva Lev-Ari, PhD, RN

This report covers the following product categories

Heart Valve Frames:

Transcatheter Aortic-Valve Implantation (TAVI) and Replacement (TAVR)
Aortic-Valve Implantation and Replacement in Open Heart Surgery (AVR)
Mitral Valve

Stents:

Coronary stents
Neurovascular stents
Carotid stents
Peripheral stents
Biliary stents

Surgical tools:

Endoscopic surgical tools
Guide wires for trans-catheter interventions (angioplasty)

The National Leader Supplier Edwards Lifesciences and its SAPIEN product for Transcatheter Aortic-Valve Implantation (TAVI) and Replacement (TAVR) is covered in Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market 6/20/2012

The ecosystem of Cardiac and Vascular Surgery for Repair or Replacement by Implantation of a new blood vessel or medical device covers the following procedure-related devices and tools now in use:

Arterial catheterization kit
Embolectomy catheters
Occlusion catheter
Coronary stents
Neurovascular stents
Carotid stents
External and internal carotid shunts
Peripheral stents
Biliary stents
Micro vascular clips
Stainless steel tunneler vascular graft
Cardiopulmonary bypass vascular catheter
Coronary stent graft system
Catheter tip occluder
Synthetic/biological composite vascular graft
Valvulotome tools
Aortic Valve
Mitral Valve
Angioplasty Guided Wires

Product Category Total US and Total Global Suppliers, Suppliers in MA by Product, Segment Industry Concentration in the US and in MA

Cardiology & Vascular Surgery Tools and Devices in use	Total number of Suppliers	GlobalSupplier	US Supplier	Suppliers in Massachusetts	Segment ConcentrationRatio in US Market	Segment Concentration Ratio in the State of MA
Arterial catheterization kit	10[MA=2]	4	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Smiths Medical ASD, Inc Weston	5.6	3.6
Embolectomy catheters	39[MA=3]	11	28	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge Boston Scientific Corporation www.bostonscientific.com Natick	1.9	2.4
Occlusion catheter	8[MA=3]	1	7	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Boston Scientific Corporation www.bostonscientific.com Natick Telemed Systems Inc. www.telemedsystems.com Hudson	2.8	2.4
Coronary stents	45[MA=2]	11	34	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Boston Scientific Corporation www.bostonscientific.com Natick	1.7	2.6
Neurovascular stents	8[MA=1]	2	6	Boston Scientific Corporation www.bostonscientific.comNatick	4.5	5.5
Carotid stents	13[MA=1]	1	12	Boston Scientific Corporation www.bostonscientific.comNatick	1.7	5.5
External and internal carotid shunts	7[MA=2]	2	5	Bard Electrophysiology www.bardep.comLowell Lemaitre Vascular, Inc. www.lemaitre.com Burlington	5.5	3.7
Peripheral stents	7[MA=1]	0	7	Boston Scientific Corporation www.bostonscientific.comNatick	1.0	1.0
Biliary stents	20[MA=1]	7	13	Boston Scientific Corporation www.bostonscientific.comNatick	3.1	3.6
Micro vascular clips	9[MA=2]	3	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Life Instrument Corporation www.lifeinstruments.com Braintree	5.2	3.7
Stainless steel tunneler vascular graft	6[MA=1]	3	3	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	10.0	5.1
Cardiopulmonary bypass vascular catheter	53[MA=5]	14	39	Abiomed, Inc. www.abiomed.comDanvers Vortex Medical Inc www.angiovac.com Norwell Lemaitre Vascular, Inc. www.lemaitre.com Burlington Clinical Instruments Intl., Inc. Southbridge Smiths Medical ASD, Inc Weston	1.6	2.0
Coronary stent graft system	6[MA=1]	0	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	1.0	1.0
Catheter tip occluder	7[MA=2]	1	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Clinical Instruments Intl., Inc. Southbridge	3.3	3.3
Synthetic/biological composite vascular graft	8[MA=2]	3	5	Lemaitre Vascular, Inc. www.lemaitre.comBurlington Boston Scientific Corporation www.bostonscientific.com Natick	6.3	3.7
Valvulotome tools	9[MA=1]	3	6	Lemaitre Vascular, Inc. www.lemaitre.comBurlington	5.2	5.1
Aortic Valve	11[MA=0]	2	9	none	2.9	10.0
Mitral Valve	11[MA=0]	4	7	none	4.8	6.4
Angioplasty Guided Wires	21[MA=2]	8	11	Arrow International, Walrus DivisionWoburn Boston Scientific Corporation www.bostonscientific.com Natick	3.7	3.0

Source: Name of products and Names of Suppliers were extracted from: http://www.medicregister.com/Cardiology_Vascular_Surgery/Categories/cid2.htm

Industry Segment Concentration Ratio: Impact on Market Penetration Cost and Potential Revenue and Market Share per Product Line

Industry Concentration Ratios per Product Line in the Cardiac and Vascular Medical Devices Segments
A	B	C	D	E	F	G	H	I	J
		US comparison				MA comparison
Cardiology & Vascular Surgery Tools and Devices in use	Global Suppliers	US Suppliers	Market share	Global ratio	Index	MA Suppliers	Market share	Global ratio	Index
Arterial catheterization kit	4	6	0.09	0.40	5.6	2	0.14	0.67	3.6
Embolectomy catheters	11	28	0.03	0.28	1.9	3	0.07	0.79	2.4
Occlusion catheter	1	7	0.11	0.13	2.8	3	0.20	0.25	2.4
Coronary stents	11	34	0.02	0.24	1.7	2	0.07	0.85	2.6
Neurovascular stents	2	6	0.11	0.25	4.5	1	0.25	0.67	5.5
Carotid stents	1	12	0.07	0.08	1.7	1	0.33	0.50	5.5
External and internal carotid shunts	2	5	0.13	0.29	5.5	2	0.20	0.50	3.7
Peripheral stents	0	7	0.13	0.00	1.0	1	0.50	0.00	1.0
Biliary stents	7	13	0.05	0.35	3.1	1	0.11	0.88	3.6
Micro vascular clips	3	6	0.10	0.33	5.2	2	0.17	0.60	3.7
Stainless steel tunneler vascular graft	3	3	0.14	0.50	10.0	1	0.20	0.75	5.1
Cardiopulmonary bypass vascular catheter	14	39	0.02	0.26	1.6	5	0.05	0.74	2.0
Coronary stent graft system	0	6	0.14	0.00	1.0	1	0.50	0.00	1.0
Catheter tip occluder	1	6	0.13	0.14	3.3	2	0.25	0.33	3.3
Synthetic/biological composite vascular graft	3	5	0.11	0.38	6.3	2	0.17	0.60	3.7
Valvulotome tools	3	6	0.10	0.33	5.2	1	0.20	0.75	5.1
Aortic Valve	2	9	0.08	0.18	2.9	0	0.33	1.00	10.0
Mitral Valve	4	7	0.08	0.36	4.8	0	0.20	1.00	6.4
Angioplasty Guided Wires	8	11	0.05	0.42	3.7	2	0.09	0.80	3.0
					126				27
Source for A, B, C, G – http://www.medicregister.com
Source for D,E,F,H,I,J -Computed ratios per formulas below by Aviva Lev-Ari, PhD, RN
D = 1/(1+B+C) = projected market share assuming non-differential production capacity

E = B/(B+C) = fraction of global among all suppliers

F = DE$F$24+1 = product of “D” and “E”, scaled to be in the range from 1 to 10

“H” is the same as “D” but with MA suppliers replacing “US suppliers”
“I” is the same as “E” but with MA suppliers replacing “US suppliers”
“J” is the same as “F” but with MA suppliers replacing “US suppliers”

Penetration Strategy for a Global Supplier Targeting the US Market and the Massachusetts Market

Customized predictions of penetration cost and estimation of potential revenues based on the industry segment concentration ratios in the Table above are part of an Actionable Strategic Market Entry Plan into the US market.

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National Medical Device Suppliers within the Cardiac and Vascular Repair Market by Product Category

Cardiology vascular surgery – The OR equipment

Bard Electrophysiology www.bardep.com

Lowell, Massachusetts Bard Electrophysiology develops & markets products, which aid in the diagnosis and treatment of electrophysiology disorders. Our products include therapeutic, diagnostic & mapping, intracardiac access, temporary pacing electrodes, and EP systems. Our Scorpion®2 Ablation Catheter brings exception more…

Edwards Lifesciences Corporation www.edwards.com

Irvine, California Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve diseases. Our embolectomy catheters are more…

Bridgepoint Medical, Inc. www.bridgepointmedical.com

Plymouth, Minnesota Bridgepoint Medical, Inc. deals with the field of interventional cardiology for access to and treatment of chronic total occlusions(CTOs). The Crossboss™ CTO catheter and the Stingray™ CTO re-entry system are used to improve physician access to chronic total occlusions. This occlusion oc more…

Futurematrix Interventional +1-(903)-6779166

Athens, Texas Futurematrix Interventional supplies a range of disposable medical devices. Our products include catheters and stents, angioplasty & angiography catheters, vascular stent delivery systems, hydrophilic urethral stents, and biopsy guns. We provide radiology, cardiology, and urology applications. We al more…

Edwards Lifesciences Technology Sarl +1-(949)-250-2500

Anasco Edwards Lifesciences Technology Sarl offers surgical products. Our products include angiography catheters, arterial blood sampling kit, central venous catheter kit, disposable pressure dome, irrigation catheter, fluid delivery tubing, vascular clamps, physiological patient monitors, intravascular ad more…

Peridot Corporation www.peridotcorp.com

Pleasanton, California Peridot Corporation specializes in the production of medical products. We provide pulmonary drug delivery systems, cardiovascular & gastrointestinal treatments, rf/thermal ablations, laproscopic, endoscopic instruments, & arthroscopic instruments, chemotherapy & stent delivery systems and catheters. more…

Medtronic Ablation Frontiers LLC www.ablationfrontiers.com

Carlsbad, California Medtronic Ablation Frontiers LLC is specialized in the treatment of ablation therapy by developing safety devices & solutions for individuals suffering from atrial fibrillation & other cardiac arrhythmias. Our product, cardiac ablation per-cutaneous catheter provides a minimally invasive treatment f more…

Endophotonix, Inc +1-(651)-452-3000

Eagan, Minnesota Endophotonix Inc. designs and manufactures laser-based surgical ablation systems. The products are indicated for the delivery of laser light for the incision, excision, dissection, vaporization, ablation or coagulation of soft tissue, including cardiac tissue, during surgical procedures. The Atrilaz more…

Csa Medical, Inc. www.csamedical.com

Baltimore, Maryland Csa Medical, Inc. deals with cryospray ablation systems. Our cryospray ablation system removes diseased tissue by rapidly freezing and thus destroying the unwanted tissue. The system transports low-pressure liquid nitrogen through a specially designed catheter that is passed through a standard endos more…

Guidant Corporation www.guidant.com

St. Paul, Minnesota Guidant Corporation is involved in the design and development of cardiovascular medical products. We offer products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vascular diseases. Our implantable cardioverter defibrillators are used to treat heart rhythms that are more…

Biotronik GmbH & Co. www.biotronik.com

Germany Biotronik GmbH & Co. manufactures medical products for the electrotherapy of the heart and vascular intervention. Our astron pulsar self-expanding stent utilises technology in stent conception to create a device that ensures flexibility & improved vessel wall scaffolding. Our Pheron® offers a le more…

Medtronic CryoCath LP www.cryocath.com

Quebec, Canada Medtronic CryoCath LP is a medical technology company that creates catheters & probe-based cryotherapy products to treat cardiovascular diseases. We offer products such as Freezor®, Freezor® Xtra, Freezor® MAX & CryoConsole. Our product medtronic cryocath has developed a minimally invasiv more…

Cardima, Inc. www.cardima.com

Fremont, California Cardima, Inc. designs, manufactures & markets microcatheter systems for the mapping & ablation of cardiac arrhythmias. Arrhythmias are abnormal electrical heart rhythms that adversely affect the mechanical activities of the heart and can significantly affect a person’s quality of life & be potential more…

Alsius Corporation www.alsius.com

Irvine, California Alsius Corporation specializes in intravascular thermal regulation technology. Our Icy™ catheter is inserted into the femoral vein and resides in the inferior vena cava. It delivers target temperature and control rewarm after cooling in neuro surgery & cardiac surgery. All Alsius® heat exc more…

Flowcardia, Inc. www.flowcardia.com

Sunnyvale, California Flowcardia, Inc. deals with the design and development of a portfolio of catheter-based technologies to facilitate guidewire crossing of totally occluded coronary & peripheral arteries. Our Crosser® 14 catheter uses high-frequency vibration to facilitate navigation of guidewires beyond chronic t more…

Venetec International, Inc. venetec.com

San Diego, California Venetec International, Inc. supplies medical products. We specialize in catheter securement technology. Our Statlock® devices protect patients and healthcare workers by reducing potential complications & accidental needlesticks. Our StatLock® stabilization devices replace tape & suture, redu more…

Codman & Shurtleff, Inc. www.codman.com

Raynham, Massachusetts Codman & Shurtleff, Inc. develops and markets a wide range of diagnostic & therapeutic products for the treatment of central nervous system disorders. Our focus is on intractable pain management, pediatric & adult hydrocephalus, and neuro critical care. Our product line includes drug pumps, cerebros more…Geister Medizintechnik GmbH www.geister.com

Tuttlingen, Germany Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, neuro and powered. We develop innovative product and process solutions for coronary artery bypass gr more…

Kaisers Surgical Instruments Pty Ltd www.kaisers.com.au

Western Australia, Australia Kaisers Surgical Instruments Pty Ltd is a supplier of high quality Kaiser branded surgical instruments. Our instrument menu comprises of orthopaedic, ophthalmic, general, ENT and cardio instruments. Our repair service offers a fast and efficient means of restoring damaged surgical instruments regard more…

Arterial catheterization kit suppliers

Arrow International, Inc. www.arrowintl.com

Reading, Pennsylvania Arrow International, Inc. combines technology and product innovation to extend the use of catheterization for the diagnosis & treatment of critically ill patients. Our disposable critical care catheterization products are used principally to access the central vascular system for administration of f more…

Lemaitre Vascular, Inc. www.lemaitre.com

Diablo Sales & Marketing, Inc. www.diablosales.com

Diablo, California Diablo Sales & Marketing, Inc. specializes in OEM components to the medical device and high technology sectors. We provide resources for new product designs incorporating the latest engineered material design technologies. We have access to CAD/CAM, solid works and pro/engineer technology for design more…

Angiodynamics, Inc. www.angiodynamics.com

Queensbury, New York Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vascular disease. Our product line includes market-leading radio frequency ablation systems, vascular ac more…

Smiths Medical ASD, Inc

Weston, Massachusetts Smiths Medical ASD, Inc supplies devices that are used during critical & intensive care, surgery, post-operative care during recovery & in a series of high-end home infusion therapies. We focus on developing technologies that offer both clinical & economic advantages to our healthcare providers and more…

Ayra Medikal Yatirimlar Limited Sirketi

Dikmen, Turkey Ayra Medikal Yatirimlar Limited Sirketi manufactures and distributes range of disposable medical devices for use in cardiology, radiology, critical care unit and operation rooms. more…

Intra Special Catheters GmbH www.intra-online.de

Germany Intra Special Catheters GmbH specilizes in catheters. Our product range comprises of arterial catheters, thoracic drainage catheters, central venous catheters and catheters for vessel surgery. The Microseld PTFE is suited for non-traumatic puncture of peripheral arteries for complication-free positi more…

Marconi Medizintechnik Deutschland GmbH +49-(6122)-9140

Germany Marconi Medizintechnik Deutschland GmbH offers medical products. more…

Biomedical Industry Group Inc. www.biomedgroup.com

Ontario, Canada Biomedical Industry Group Inc. manufactures Rollachair™, Needlegard™, Catheterdriver™ and Arterialpressurestand™. Our Rollachair™ is hygienic and meets infection control standards. Our pressure stand is used with a sterile pad during arterial catheterization process. more…

Embolectomy catheters suppliers

Arrow Internacional De Mexico, S.A. De C.V. +52-(610)-378-0131

Mexico Arrow Internacional De Mexico, S.A. De C.V. offers multiple sterile needleless injection hub, wire guides and various intravascular catheters. more…

Atrium Medical Corporation www.atriummed.com

Hudson, New Hampshire Atrium Medical Corporation manufactures breakthrough medical device technologies used in open heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels. We are an ISO 9000, ISO 9001, ISO 9002 & CE MARK certified company. We offer products like cardiology, more…

Ev3, Inc. www.ev3.net

Plymouth, Minnesota Ev3, Inc. is a medical device company that focuses on catheter based or endovascular, technologies for the minimally invasive treatment of vascular diseases and disorders. We offer neuro products such as embolic coils, liquid embolics, micro catheters, Guidewires, balloons, carotoid stents & embolic more…

Alsius Corporation www.alsius.com

Cook Vascular IncorporatedSEND INQUIRY

Vandergrift, Pennsylvania Cook Vascular Incorporated provides interventional, therapeutic and diagnostic vascular products. We also manufacture a complete line of Vital-port® vascular access ports and a wide variety of catheters, introducers & specialty components. Our lead extraction system is a collection of specialize more…

Vascular Solutions Inc. www.vascularsolutions.com

Minneapolis, Minnesota Vascular Solutions Inc. develops products for the interventional cardiologist and interventional radiologist. Our D-Stat products are based on the scientifically proven hemostatic power of thrombin. Our Vari-Lase endovenous laser system is designed to help physicians provide advanced treatment for v more…

Cook Group Incorporated www.cookgroup.com

Bloomington, Indiana Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blocker set allows one-lung ventilation using a conventional endotrachael tube and a pediatric fiberopt more…

Cordis Corp. +1-(786)-313-2000

Miami Lakes, Florida Cordis Corp., a Johnson & Johnson company develops products to treat circulatory system diseases including congestive heart failure and cerebral aneurysms. Its product lines include the balloons, catheters, forceps, guidewires, and plain and drug-coated stents used in cardiology, endovascular, and n more…

Edwards Lifesciences Corporation www.edwards.com

Medtronic Xomed Surgical Products, Inc www.xomed.com

Jacksonville, Florida Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, Integrated Power Console System, Pillar® System, Big Easy® Piston, and ENT-5000 Video Endosco more…

Merit Medical Systems, Inc. www.merit.com

South Jordan, Utah Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic catheters, guide wires, pressure monitoring disposables, fluid delivery systems, medication syringe more…

Medtronic, Inc. www.medtronic.com

Minneapolis, Minnesota Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascular, neuromodulation, diabetes, and surgical technologies. Our cardiac resynchronization therapy (CR more…

Hotspur Technologies, Inc. www.hotspur-inc.com

Mountain View, California Hotspur Technologies, Inc. develops catheter-based technologies aimed at restoring blood flow for patients with obstructed vessels. The IQCath™ balloon dilatation catheter is a specialty three-in-one device that allows the physician to perform angioplasty, deliver targeted contrast, and perfor more…

Nexgen Medical Systems, Inc.SEND INQUIRY

Reno, Nevada Nexgen Medical Systems, Inc. specializes in developing medical devices. Our medical devices improve safety & efficacy of interventional procedures in patients with neurological and cardiovascular diseases. Our products include embolic protection device, and mechanical clot retrieval device. We provi more…

Pfm Medical, Inc www.pfmmedical.com

Oceanside, California Pfm Medical, Inc specializes in products such as EZ Huber®, pfm PICC Catheters, and interventional cardiology. The EZ huber isolates the caregiver from harmful patient fluids and oncology drug splatter. PICC catheters & trays provides increased flexibility to both administer and medications & pe more…

Lemaitre Vascular, Inc. www.lemaitre.com

Micrus Endovascular Corporation www.micrusendovascular.com

San Jose, California Micrus Endovascular manufactures & markets both implantable and disposable medical devices used in the treatment of cerebral vascular diseases. Our products are used by interventional neuroradiologists and neurosurgeons primarily, to treat cerebral aneurysms in the brain which are responsible for he more…

Spectranetics Corporation, The www.spectranetics.com

Colorado Springs, Colorado The Spectranetics Corporation manufactures and markets the excimer laser system for use in minimally invasive interventional procedures within the cardiovascular system. The spectranetics laser system utilizes a wavelength of 308 nanometers in the ultraviolet region of the light spectrum. The laser more…

Artegraft, Inc. www.artegraft.com

North Brunswick, New Jersey Artegraft, Inc. specializes in offering Collagen Vascular Graft™. Artegraft is a natural collagen vascular graft. Its biological fibrous matrix is processed to enhance long term patency and provide a tightly woven, cross-linked conduit that is flexible & compliant. It is used for segmental byp more…

Arrow International, Inc www.neocare.com

San Antonio, Texas Arrow International, Inc. develops, manufactures and markets a broad range of catheter based therapeutic products. Our Arrow SmartSeal™ hemostatic peelable dialysis sheath is designed to minimize risk of air embolism, minimize blood loss, and reduce clinician’s exposure to blood-borne pathogen more…

Lumen Biomedical, Inc. www.lumenbio.com

Plymouth, Minnesota Lumen Biomedical, Inc. offers interventional devices for embolic protection and thrombus removal throughout the body. Our FiberNet® embolic protection system features a low crossing profile for optimal device deliverability. Its proprietary filter design promotes conformability to asymmetrical v more…

Lucas Medical, Inc. www.lucasmedicalinc.com

Anaheim, California Lucas Medical, Inc. specializes in silicone medical products. Our product portfolio comprises of embolectomy catheters, occlusion catheters, biliary catheters, carotid shunts, thrombectomy catheters, straight irrigation catheters and bi-lumen irrigation catheters. Our arterial embolectomy catheters more…

Clinical Instruments Intl., Inc. +1-(508)-764-2200

Southbridge, Massachusetts Clinical Instruments Intl., Inc. provides carotid bypass shunt, introducers and detergent reagent. more…

Biosensors International USA www.biosensors.com/usa

Newport Beach, California Biosensors International USA develops, manufactures and markets medical devices for interventional cardiology & critical care procedures. Acutrans™ is our fully disposable blood pressure transducer system that is used in invasive blood pressure measurement with lowest possibility of zero drift more…

Applied Medical www.appliedmedical.com

Rancho Santa Margarita, California Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdominal access system, Acucise® endopyelotomy/endoureterotomy system, Direct Drive® graspers a more…

Sorin Group USA, Inc. www.soringroup-usa.com

Arvada, Colorado Sorin Group USA, Inc. designs and manufactures cardiac perfusion & blood management systems. Our D100 oxygenator is designed for neonatal procedures. It is designed to reduce allogenic blood product usage and can have a positive effect on patient outcomes. The flow rates are under 700 cc/minute. Our more…

Edwards Lifesciences Technology Sarl +1-(949)-250-2500

Medrad, Inc. www.medrad.com

Warrendale, Pennsylvania Medrad, Inc. deals in medical devices and services that enable & enhance imaging procedures of the human body. We are engaged in the production of vascular injection systems for diagnostic or interventional procedures. We manufacture and market a complete line of CT injection systems. We also offer more…

Boston Scientific Corporation www.bostonscientific.com

Natick, Massachusetts Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division concentrates on providing medical treatment to cardiovascular, peripheral vascular & neurovascular dis more…

Venetec International, Inc. venetec.com

Biosensors Intl. Pte. Ltd. www.biosensors.com

Singapore Biosensors Intl. Pte. Ltd. serves as the manufacturing centre for critical care products such as embolectomy catheters, thermodilution catheters,and central venous catheters. more…

Senko Medical Trading Co. www.senko-trd.co.jp

Japan Senko Medical Trading Co. distributes medical products. We focus on cardiothoracic, surgical products, anesthesia, and otolaryngologic products. more…

Invatec Innovative Technologies, S.R.L. www.invatec.com

Italy Invatec Innovative Technologies, S.R.L. is a producer of catheters. Our coronary products include Falcon CTO, Piccolo, Bravo, Grande & Forte, Avion plus, Skylor and Skipper. Our peripheral products are Hippocampus, Scuba, Admiral xtreme, Maris plus & deep. Our Falcon CTO balloon catheter provides so more…

3by Ltd. www.3by.com

Israel 3by Ltd. specializes in turn-key projects of medical components, devices and systems. We provide clean room production, sophisticated plastic injection molding services, technical design assistance, assembly and product testing. Our solutions include injection, automatic assembly, product testing an more…

Pfm Produkte für die Medizin AG www.pfm-ag.de

Germany Pfm Produkte für die Medizin AG is a marketing and sales specialist for medical technology products in the fields of pathology/histology, OP/anesthesia, infusion therapy & interventional technologies. We offer various products including anterior chamber cannulas, anti roll device sets, aprons, arter more…

Intra Special Catheters GmbH www.intra-online.de

Dispomedica GmbH www.dispomedica.de

Germany Dispomedica GmbH deals with healthcare products under categories such as anesthesia, neuro surgery, cardio surgery and sterilization. The ventricular catheters are designed for temporary drainage of cerebrospinal fluid (CSF), in order to reduce and control intracranial pressure. The temporary myocar more…

Vascutech, Inc. +33-(800)-628-9470

France Vascutech, Inc. provides vascular balloon catheter and biliary catheter. more…

Occlusion catheter suppliers

Lemaitre Vascular, Inc. www.lemaitre.com

Catheter Research, Inc. (CRI) www.catheterresearch.com

Indianapolis, Indiana Catheter Research, Inc. (CRI) is a manufacturer and developer of medical devices. We specialize in catheters, tubing and OEM medical device manufacturing. We have numerous patents describing various catheters and similar medical devices with single and multiple elements of shape memory nitinol. The more…

Telemed Systems Inc. www.telemedsystems.com

Hudson, Massachusetts Telemed Systems Inc. is manufacturer of medical accessory devices which are utilized with the flexible endoscope in the field of gastroenterology. Our product line includes polypectomy snares, gastrointestinal cytology brushes, bronchial cytology brushes, balloon catheters, disposable sclerotherapy more…

Boston Scientific Corporation www.bostonscientific.com

Dispomedica GmbH www.dispomedica.de

Billary stents

Vitae Core www.vitaecore.com

Cypress, California Vitae Core is a specialized medical device company involved in the marketing and distribution of OEM/branded products. We offer urology, radiology, gastroenterology, braces/back supports, scissors and dental instruments. Our urology products include urethral balloon catheter, slings, nephrostomy bal more…

Cordis Corp. +1-(786)-313-2000

Polymerex Medical Corp. www.polymerex.com

San Diego, California Polymerex Medical Corp. specializes in providing PTCA, PTA balloon catheters, stents and accessories. We also offer variety of components including tubing, medical balloon, luer and hub. We provide plastics, lubricious & heat shrink tubing, biliary, esophageal & tracheal stent, torque device and ins more…

Flexible Stenting Solutions, Inc. www.flexiblestent.com

Eatontown, New Jersey Flexible Stenting Solutions, Inc. is engaged in the business of stents. Our stenting solutions technology is designed for the harsh loading conditions in the superficial femoral and popliteal arteries, which are in the dominant sites and peripheral vascular diseases. Our fully connected stent has co more…

Allwin Medical Devices, Inc. www.allwinmedical.com

Anaheim, California Allwin Medical Devices, Inc. manufactures urology products. Our urology products include biopsy needles, dilators, guidewires, stone buster pneumatic lithotripters, meatal dilators and urinary diversion stents. We offer needles, catheters, drainage sets, speciality stents, stent removers, stone bask more…

Cordis Corporation, A Johnson & Johnson Co. www.cordis.com

Warren, New Jersey Cordis Corporation, A Johnson & Johnson Co. is a developer and manufacturer of breakthrough stents, catheters and guidewires for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. We offer products for cardiology, endovascular, and biliary. Our brands include more…

Idev Technologies, Inc. www.idevtechnologies.com

Houston, Texas Idev Technologies, Inc. supplies medical device products designed for endovascular interventional use. Our Supera® transhepatic biliary stent uses the novel wire interwoven nitinol (WIN) design which offers great conformity to the natural biliary duct and 1:1 nominal sizing. Above or below the k more…

Medi-Globe Corporation www.mediglobe.com

Tempe, Arizona Medi-Globe Corporation is a developer, manufacturer and distributor of instruments, catheters, devices, implants & equipment for flexible endoscopy, urology, cardiology and wound care. We also distribute a wide range of hospital supplies. We focus on the minimally invasive surgical market with speci more…

Hobbs Medical Inc. www.hobbsmedical.com

Stafford Springs, Connecticut Hobbs Medical Inc. specializes in the design and development of diagnostic & therapeutic accessories for the gastrointestinal & pulmonary market. Our achalasia balloon dilator is manufactured from specially treated polyurethane. It has standard luer-lock fittings for compatibility with inflation/def more…

Bard Peripheral Vascular, Inc. www.bardpv.com

Tempe, Arizona Bard Peripheral Vascular, Inc. deals with vascular products. Our product list comprises of abdominal/thoracic grafts, hemodialysis access grafts, peripheral bypass grafts, stents, stent grafts, and venacava filters. The LifeStent® vascular stent has a combination of helical structures, encompass more…

Boston Scientific Corporation www.bostonscientific.com

Abbott Laboratories www.abbott.com

Abbott Park, Illinois Abbott Laboratories is a diversified health care company which discovers, develops, manufactures and markets innovative products & services that span the continuum of care from prevention, diagnosis to treatment & cure. We focus on advancing medical science & the practice of health care with experti more…

Guidant Corporation www.guidant.com

Olympus KeyMed Ltd. www.keymed.co.uk

Essex, United Kingdom Olympus KeyMed Ltd. manufactures and supplies specialized medical & industrial equipments. We manufacture high-quality electro-optical products, such as cameras & microscopes and endoscopic instrumentation for both medical & industrial applications. Our product categories are laparo-endoscopic singl more…

ACE Medical Devices Pvt. Ltd.SEND INQUIRY

Maharashtra, India Ace Medical Devices Pvt. Ltd. manufactures and distributes medical devices. We are an ISO 9001:2001 and ISO 13485 certified company. Our products are CE-certified in accordance with MDD 93/42/EEC. We offer urology & gastro disposables, and disposable laparoscopic scissors. Our products include ureth more…

Manish Medi-Innovation saimanish.com

Karnataka, India Medi-Innovation produces super specialty surgical disposables in the field of urology, gynaecology and gastroenterology. We deal in stents, catheters, dilators, guide wire, graspers, IP needles, penile clamps, stone baskets and rigid graspers. Endoscopic biliary stents, endoscopic biliary drainage c more…

Aster Medispro Pvt Ltd www.astermedispro.net

Karnataka, India Aster Medispro produces medical devices in the specialities of urology, radiology, gastroenterology and gynaecology. Our products include PCN catheter, malecot catheter, suprapublic catheter, prostatic stent, ureteral dilator, stone basket, stone grasper, loop stent, and tieman. Our urethral indwell more…

Medi-Globe GmbH www.medi-globe.de

Germany Medi-Globe GmbH produces and distributes minimal-invasive instruments & accessories used in the fields of gastroenterology & flexible endoscopy. We also deal with wound care systems. We have DIN EN ISO 13485: 2003 certification to our credit. Some of our products are biopsy forceps, foreign body ret more…

Taewoong Medical Co., Ltd www.stent.net

Korea, Republic Of Taewoong Medical Co., Ltd develops stents. Our GI stents are used to maintain or restore the lumen of hollow organs, vessels, and ducts. Non-vascular stents are devices to create an artificial pathway, open for hollow lumen organs that are closed or obstructed due to cancerous lesions or benign dise more…

Medinol Ltd. www.medinol.com

Israel Medinol Ltd. specializes in the manufacture of cardiology products with the invention of the flexible closed cell stent design. We focus on the stent technology to combine thicker and thinner strut to optimize the balance between flexibility and scaffolding. Our product line comprises of Nirflex® more…

Carotid shunts suppliers

C. r. Bard, Inc. www.crbard.com

Murray Hill, New Jersey C. r. Bard, Inc. manufactures and markets life-enhancing medical technologies in the fields of vascular, urology, oncology & surgical specialty products. We are an ISO 9000 certified company. We offer products by business unit, disease state, process listing, idea generation process, OEM & E commerc more…

Bard Electrophysiology www.bardep.com

Lemaitre Vascular, Inc. www.lemaitre.com

Perouse Medical www.perouse.com

France Perouse Medical specializes in cardiovascular surgery, oncology and interventional imaging fields. Our products for cardiovascular surgery include knitted and woven polyester vascular prostheses, balloon catheters, carotid shunts and vein strippers. Our implantable catheter port is flexible and with more…

External and internal carotid shunts suppliers

Sophysa USA, Inc. www.sophysa.com

Crown Point, Indiana Sophysa USA, Inc. specializes in adjustable valves. Our lumbo-peritoneal catheter kit is a complete set that ensures drainage of cerebrospinal fluid (CSF) from the subarachnoid space of the spine to a sophy valve & from the valve to the peritoneal cavity. Our Pulsar® valve is endowed with a one way device & allows patency checking & CSF access & is available in 2 sizes and 3 pressure ranges. Our infusion sets to be used with Soph-A-Port implantable access port are available, simple or with l more…

Lemaitre Vascular, Inc. www.lemaitre.com

Burlington, Massachusetts LeMaitre Vascular, Inc. is a global provider of devices for the treatment of peripheral vascular disease. We develop, manufacture, and market disposable & implantable vascular devices to address the needs of vascular surgeons & interventionalists. Our product portfolio consists of brand name products used in arteries and veins outside of the heart. We offer stent grafts, biologic vascular patch, carotid shunts, covered stents, contrast injector, and implantable ports. The UniFit aorto-uni-iliac more…

Micro vascular clips suppliers

Roboz Surgical Instrument Co., Inc. www.roboz.com

Gaithersburg, Maryland Roboz Surgical Instrument Co., Inc. specializes in providing hand-crafted surgical instruments. Our surgical instruments include tweezers & forceps, bone instruments, surgical & vascular clips & clamps, scalpels, retractors, wound closure & vascular access instruments, instrument care & handling pro more…

Stoelting Co. www.stoeltingco.com

Wood Dale, Illinois Stoelting Co. produces and distributes instruments for basic biomedical research in neuroscience & physiology. Our ANY-maze™ is a flexible video tracking system designed to automate testing in behavioural experiments more…

Aesculap Inc. www.aesculapusa.com

Center Valley, Pennsylvania Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Our cardiovascular instruments includes peripheral vascular, aorta, anastomosis clamps, vascular clips more…

Lemaitre Vascular, Inc. www.lemaitre.com

RZ-Medizintechnik Gmbh www.rz-medizintechnik.com

Germany RZ-Medizintechnik GmbH offers standard and speciality instruments & accessories for various surgical fields such as arthroscopy, ENT, urology, ophthalmology, & plastic surgery. We offer a complete set of laryngoscopes for adults and children. These laryngoscopes permit a good view of the laryngeal a more…

Stainless steel tunneler vascular graft suppliers

Teleflex Medical www.teleflexmedical.com

Research Triangle Park, North Carolina Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical devices and orthopedic surgical instruments. Our OEM brands include Beere Medical, KMedic, Deknatel more…

Lemaitre Vascular, Inc. www.lemaitre.com

C. R. Bard, Inc., Bard Medical Div. www.bardmedical.com

Covington, Georgia C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry’s comprehensive product inventory for patient care. We offer a full line of Foley catheters including infection c more…

Zeppelin Medical Instruments Ltd. www.zeppelin.md

Germany Zeppelin Medical Instruments Ltd. produces and distributes medical products. Our haematoscope is designed for neuro endoscopic surgery where a large working channel and best image information is needed. Our trepanmotor is designed in particular for the cranial burr hole trepanation at low speed. Our more…

General Surgical Co., (india) Pvt. Ltd. www.gescoindia.com

Tamil Nadu, India General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic, cardio thoracic, urology, oncology, vascular, ophthalmic, dental, oral & maxillofacial surgery ins more…

Baur Und Haselbarth-Chirurg Gmbh www.bh-chirurg.de

Germany Baur Und Haselbarth-Chirurg GmbH is a manufacturer of surgical instruments. We manufacture a broad variety of surgical instruments including aspiration & suction instruments, atomizers, ear specula, gynecological instruments, retractors, trachea tubes and rectal instruments. Our aspiration & suction more…

Vascular stent suppliers

DRG International, Inc. www.drg-international.com

Mountainside, New Jersey DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoassays & lab equipments. Our enzyme immunoassays include adrenocorticotropic hormone, alpha fetoprotei more…

Atrium Medical Corporation www.atriummed.com

Cordis Corp. +1-(786)-313-2000

Vascular Architects, Inc.SEND INQUIRY

San Jose, California Vascular Architects, Inc. designs, manufactures and markets instrumentation used in the treatment of vascular stenoses, occlusions and non-vascular obstructions. A key area of emphasis is the treatment of peripheral vascular disease, which manifests itself as a reduction or loss of blood flow due to more…

Lemaitre Vascular, Inc. www.lemaitre.com

Fort Wayne Metals www.fwmetals.com

Fort Wayne, Indiana Fort Wayne Metals specializes in the research, development and production of fine grade medical wire. We work with stainless steel, titanium and titanium alloys and specialty alloys such as nitinol. Our products include flat and shaped wires, center less and precision ground bar, drawn filled tubing more…

Bard Peripheral Vascular, Inc. www.bardpv.com

Micro-tech (Nanjing) Co., Ltd. www.micro-tech.cn/indexen.htm

Jiangsu, China Micro-tech (Nanjing) Co., Ltd develops, manufactures & distributes stents series products, biopsy forceps and other medical devices for minimal invasive operation. We perform sterilization inspection for our single use medical devices. Our product line includes biliary duct, colonic, duodenal, esoph more…

Tayside Flow Technologies Limited www.tayflow.com

United Kingdom Tayside Flow Technologies Limited focuses on the development of vascular devices. We offer vascular devices that are based on blood flow dynamics spiral laminar flow technology. Our SLF™ spiral grafts are monitored by conventional techniques to determine the effects on the pressure and flow ch more…

Cardio-Nef, S.A. De C.V. www.cardionef.com

N.L., Mexico Cardio-Nef, S.A. De C.V. provides coronary stent, guide wire catheter and catheter introducer. more…

Taewoong Medical Co., Ltd www.stent.net

Contech Medical International, Ltd. www.contechireland.com

Ireland Contech Medical International, Ltd. is an OEM sub-contract manufacturer servicing the medical device industry. We offer OEM medical device assembly & packaging, winged infusion and straight needle sets, both uncoated & coated balloon, stent protectors, catheter & guide wire dispensers. Our technical more…

Micro-Tech (Nan Jing) Co., Ltd. www.stent.cc

China Micro-Tech (Nan Jing) Co., Ltd. manufactures & distributes stent series products, biopsy forceps and medical devices for minimally invasive operations. We perform sterilization inspection for single use medical devices. Our product line comprises of biliary duct, colonic, duodenal, esophageal, prost more…

Cardiopulmonary bypass vascular catheter suppliers

Autosuture www.autosuture.com

Norwalk, Connecticut Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO 9001, ISO 9002, CE MARK certified company. We offer products like endo catch™ 10mm specimen bag, end more…

Chase Medical www.chasemedical.com

Richardson, Texas Chase Medical designs & manufactures products for the comprehensive surgical treatment of congestive heart failure, including products for surgical ventricular restoration procedures and for both beating heart & traditional CABG procedures. We offer products such as catalyst, Marisa™, Mannequin & PT more…

Abiomed, Inc. www.abiomed.com

Danvers, Massachusetts Abiomed, Inc. develops & distributes heart assist and replacement systems. We offer healthcare professionals an array of choices across a broad clinical spectrum from the catheterization lab to the surgical suite, together with interventional cardiologists and surgeons. Our AbioCor is a completely s more…

Cook Group Incorporated www.cookgroup.com

Viasys Healthcare Inc www.viasyshealthcare.com

San Diego, California Viasys Healthcare Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-level nasal CPAP for the spontaneously breathing neonate through delivery of sighs above a baseline more…

Edwards Lifesciences Corporation www.edwards.com

Medtronic Xomed Surgical Products, Inc www.xomed.com

Integra LifeSciences Corporation www.integra-ls.com

Plainsboro, New Jersey Integra LifeSciences Corporation develops & markets surgical instruments, as well as devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Our Samy™ vascular retractors enable the neurosurgeon to elevate, retract and depress the vessel, t more…

Luxtec www.luxtec.com

West Boylston, Maryland Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monitors, printers, and light sources. Our ultralite consists of ergonomic designs that use the head’s nat more…

Medtronic, Inc. www.medtronic.com

Vortex Medical Inc www.angiovac.com

Norwell, Massachusetts Vortex Medical Inc specializes in novel endomechanical devices for the endovascular market. We provide AngioVac® cannula and circuit. It is a novel catheter-based device that facilitates the suction, filtering, and simultaneous reinfusion of blood. The AngioVac® cannula, a unique balloon-act more…

Endoscopic Technologies, Inc. www.estech.com

San Ramon, California Endoscopic Technologies, Inc. develops medical devices and disposables that enable cardiac surgeons to perform a variety of traditional and minimally invasive surgical procedures. Our Cobra Adhere XL™ surgical system is a minimally invasive epicardial probe that utilizes ten electrodes to crea more…

Global Blood Resources, Llc +1-(800)-9429243

Windsor, Connecticut Global Blood Resources, Llc offers cardiopulmonary bypass blood reservoir and cardiopulmonary bypass vascular catheters. more…

Pemco, Inc. www.pemcomed.com

Cleveland, Ohio Pemco, Inc. is a manufacturer of precision surgical instruments that include custom perfusion systems. Our products include anesthesia shield, suction handles, suction sets, suction tips, cannula connectors, heart pumps and retractors. Our anesthesia shield provides a protective area around the pati more…

Cardeon Corp. +1-(408)-253-3319

Cupertino, California Cardeon Corp. specializes in providing various catheters, cannula & tubing, vascular and cardiopulmonary bypass products. more…

Cardiac Assist, Inc. www.cardiacassist.com

Pittsburgh, Pennsylvania CardiacAssist, Inc. develops, manufactures and markets medical device products to provide cardiologists and cardiac surgeons. Our product range includes tandemheart cannula set, tandemheart controller and tandemheart system pump. Our tandemheart transseptal cannula set-enhanced flow 72 provides exte more…

Circulatory Technology, Inc. www.cirtec.com

Oyster Bay, New York Circulatory Technology, Inc. develops medical devices to improve the safety and efficacy of cardiopulmonary bypass. Our products include The Better-Bladder™ (BB), The V-Bag™, The Better-Header™ and The Better-Venter™. The Better-Bladder™ (BB) is an inline reservoir that more…

Lemaitre Vascular, Inc. www.lemaitre.com

Cascade Life Solutions, LLC +1-(616)-977-2505

Grand Rapids, Michigan Cascade Life Solutions, LLC are providers of tourniquet kit with snares, cardioplegia cannulae, sucker and cardiovascular accessories. more…

Avalon Laboratories, Inc. www.avalonlabs.com

Rancho Dominguez, California Avalon Laboratories, Inc. is a supplier of wire-reinforced catheters and cannulae. Our products include vascular access kits, bi-caval dual lumen and multi-port venous femoral catheters. The bi-caval dual lumen catheter is a single site, kink resistant, veno-venous device designed to enable optimal more…

Voss Medical Products vossmedicalproducts.com

San Antonio, Texas Voss Medical Products is a medical device developer/specifier specializing in surgical products. Our product categories are positioning, cardiovascular and specialty. We offer positioning devices, and graft markers, cannulas, and clamps used in coronary bypass procedures. Our single use disposable P more…

Alliant Healthcare Products www.allianthealthcare.com

Richland, Michigan Alliant Healthcare Products designs, develops, manufactures and markets products for the healthcare market. We also provide custom assembly, packaging and manufacturing for acute care hospitals, government & original equipment (OEM) for private label customers. We focus on cardiovascular, general su more…

Vitalcor, Inc. www.vitalcor.com

Westmont, Illinois Vitalcor, Inc. manufactures and distributes medical devices used primarily in cardio-thoracic surgery. We specialize in coronary artery perfusion cannulae with balloon. The balloon is made of self-inflating PVC with no latex. more…

Atek Medical www.atekmedical.com

Grand Rapids, Michigan Atek Medical is a producer of medical products. We manufacture class II and III disposable, implantable and electro-mechanical devices. We have extensive assembly capabilities that include UV bonding, ultrasonic welding, pad printing, laser marking, FFS packaging, tray sealing, bar sealing, catheter more…

Shelhigh, Inc. www.shelhigh.com

Union, New Jersey Shelhigh, Inc. offers SemiStented™ aortic tricuspid valves, stentless aortic valves, stentless valve conduit, and tricuspid valves. The NR2000 stentless aortic valves offers supravalvular implantation using single layer continuous suture line. It requires no rinsing and is available in a wide more…

California Medical Laboratories www.calmedlab.com

Costa Mesa, California California Medical Laboratories develops, distributes and manufactures cardiovascular cannulation products. Our product line includes cardiovascular cannulation products, cardioplegia products, vent catheters, suction wands, beating heart products, custom cannulation kits & accessories. Our custom c more…

Surge Medical Solutions, LLC. www.surgemedical.com

Grand Rapids, Michigan Surge Medical Solutions, LLC. provides solution for cardiovascular surgery, emergency services and emergency preparedness as well as a variety of other healthcare markets. Our retrograde provides the means for delivering cardioplegia solution to the patient’s heart. The cannulae permit delivery of c more…

Bard Shannon Limited +1-(908)-277-8000

Humacao Bard Shannon Limited supplies medical devices and diagnostic equipments. Our product line includes biopsy systems, mesh bags and precision pass. more…

Churchill Medical Systems, Inc. www.churchillmedicalsystems.com

Montgomeryville, Pennsylvania Churchill Medical Systems, Inc. is a manufacturer of procedure kits, IV sets and accessories, TPN bags & pharmacy admixture products. We offer a complete custom product program. Our extension sets include standard bore extension sets, micro bore extension sets, minibore & ultra-microbore extension s more…

C. R. Bard, Inc., Bard Medical Div. www.bardmedical.com

Jostra Bentley, Inc. +1-(302)-454-9959

Anasco Jostra Bentley, Inc. offers various surgical and disposable medical products. We provide arterial filters, blood infusion line, cardioplegia cooling/administration set, cardiotomy venous reservoirs, custom cardiovascular perfusion kits, disposable sucker, oxygen saturation meter, pleural drainage/au more…

Vygon Corp. www.vygonusa.com

Norristown, Pennsylvania Vygon Corp. deals with single-use medical and surgical products. Our neonatal & pediatric special care products are categorized as vascular access, digestive tract and respiratory tract. The PremiCath is a 27G (1.1 Fr) Flexane® catheter for mid-long term I.V.therapy. Its 24G splitting introducer more…

Clinical Instruments Intl., Inc. +1-(508)-764-2200

Southbridge, Massachusetts Clinical Instruments Intl., Inc. provides carotid bypass shunt, introducers and detergent reagent. more…

Terumo Medical Corporation +1-(410)-392-7243, 800-283-7866

Elkton, Maryland Terumo Medical Corporation deals with blood specimen collection devices, coaxial introducers, entry needles, guide wires, phlebotomy needle cap holders, and piston syringes. more…

Sorin Group USA, Inc. www.soringroup-usa.com

Terumo Cardiovascular Systems www.terumo-cvs.com

Ann Arbor, Massachusetts Terumo Cardiovascular Systems (TCVS) develops, manufactures and distributes medical devices for cardiac & vascular surgery with an emphasis on cardiopulmonary bypass, intra–operative monitoring & vascular grafting. The Fresenius continuous autotransfusion system (C.A.T.S) salvages red blood cells fo more…

Atrion Medical Products, Inc. www.atrionmedical.com

Arab, Alabama Atrion Medical Products, Inc., a division of Atrion Corporation specializes in medical devices. Our product lines provide solutions for a variety of medical markets such as cardiovascular, orthopedic, ophthalmic, urological and anesthesia. Our QL® inflation device is perfect for a wide array of more…

Smiths Medical ASD, IncSEND INQUIRY

Smiths Medical Deutschland GmbH www.smiths-medical.com/de

Germany Smiths Medical Deutschland GmbH provides medical devices for the hospital, emergency, home and specialist environments. Our Point-Lok® device is a needle safety solution for needles found in epidural, spinal and other procedural trays. Our BCI® 3301 pulse oximeter and Digit™ finger pul more…

Erika De Reynosa, S.A. De C.V. +52-(899)-921-3500

Mexico Erika De Reynosa, S.A. De C.V. specializes in offering orthopedic, prosthetic and surgical appliances & supplies. Our products include tubing clamps, catheter connectors, I.V. administration sets, single needle blood sets & accessories, and various types of blood tubing sets, transducer protectors f more…

Kelsar, S.A. +52-(0)-89-41-86

Mexico Kelsar, S.A. specializes in offering catheter bags, intraventricular probes and oxygen & bag feeder. Our Argyle DeLee suction catheter with mucous trap is intended to aspirate liquids or semisolids from a patient’s upper airway. more…

Terumo Corporation www.terumo.co.jp

Tokyo, Japan Terumo Corporation manufactures & distributes medical products & equipment that include pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, peritoneal dialysis, blood glucose monitoring system, medical electronic and digital thermometers. Our more…

Dideco S.P.A. www.sorin-cp.com

MO, Italy Dideco S.P.A. focuses on perfusion and blood management systems. Our products include endoscopic vessel harvesting, cardiopulmonary equipment, oxygenators, optimized bypass systems, venous and cardiotomy reservoirs, arterial filters, cardioplegia, hemoconcentration, monitoring, centrifugal blood pum more…

Sorin S.p.A.SEND INQUIRY

Italy Sorin S.p.A. focuses on the development of products used to treat cardiovascular and renal diseases. Our product categories are endoscopic vessel harvesting, cardiopulmonary equipments, oxygenators, arterial filters and cannulae & suckers. Our ClearGlide® ERA for endoscopic radial harvesting ena more…

DMC Medical Ltd. www.dmcmedical.net

Ireland DMC Medical Ltd. offers manufacturing, consultancy and distribution service to the medical device sector. Our product list comprises of saphenous vein distention systems, cardiac insulation pads, vein irrigation cannulas, and polycarbonate connectors. The saphenous vein distention system (SVDS) prev more…

Admedes Schuessler Gmbh www.admedes.com

Germany Admedes Schuessler Gmbh provides nitinol self expandable components to medical industries. Our product line comprises of nitinol stents, percutaneous heart valve frames, filters, occlusion devices and distal protection devices. We also specialize in laser cuttings, shape settings, surface finishes, more…

Maquet Cardiopulmonary Ag www.maquet-cp.com

Germany Maquet Cardiopulmonary Ag is a provider of medical technology for emergency rooms, operating rooms and intensive care units. We offer complete solutions for operating theatres and intensive care units. We supply OR tables, lights and complete OR solutions. Endoscopic vessel harvesting or EVH is a pr more…

Bionic Medizintechnik GmbH www.bionic-jms.com

Taunus, Germany Bionic Medizintechnik GmbH specializes in the distribution of dialysis and transfusion products. We also manufacture catheters and therapy chairs & beds. We offer a wide range of medical single-use products. We supply blood bags and equipments needed for blood transfusion. Demers-Katheter® is a more…

Vygon S A www.vygon.com

France Vygon S A offers single use medical and surgical products. We focus on urinary tract surgery, wound drainage, digestive tract, respiratory tract, neonatology, and operation theater products. Our urinary tract products include pediatric vesical catheters, rectal catheters, hourly diuresis and urine d more…

Allegiance Healthcare Corp. 847-473-1500

Dominican Republic Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more…

Davis And Geck Caribe, Ltd. 203-845-1000

Dominican Republic Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape. more…

Cardiomed Supplies Inc. www.cardiomed.com

Ontario, Canada Cardiomed Supplies Inc. is a manufacturer and distributor of disposable surgical products. We supply disposable products for open heart surgery, critical care, dialysis, and oncology. Our comprehensive product line includes renal and peritoneal dialysis catheters, catheters for intensive and critica more…

Coronary stent graft system suppliers

TriReme Medical, Inc. www.trirememedical.com

Pleasanton, California TriReme Medical, Inc. specializes in providing products for physicians to use in the treatment of coronary artery disease. We offer Antares™ coronary stent system and Glider™ PTCA balloon catheter. Our Glider™ PTCA balloon catheter can be used to dilate highly-stenosed lesions. more…

Elixir Medical Corporation www.elixirmedical.com

Sunnyvale, California Elixir Medical Corporation develops products that combine medical devices with pharmaceuticals to provide treatment solutions. Drug-eluting stent systems are designed to optimize localized drug delivery to provide a safe treatment for cardiovascular patients. Our coronary stent is manufactured from more…

Lemaitre Vascular, Inc. www.lemaitre.com

Abbott Hematology www.abbott.us

Santa Clara, California Abbott Hematology offers pharmaceutical, medical, and nutritional products. Our product range comprises of medicines, medical diagnostic instruments & tests, minimally invasive surgical devices, and a spectrum of nutritional supplements for infants, children & adults. Our perclose A-T suture medicat more…

Medtronic Neurosurgery +1-(901)-344-0645 , 800-468-9710

Goleta, California Medtronic Neurosurgery deals with cranial neurosurgery market. Our products include a wide variety of PS Medical® silicone elastomer valves, catheters, & shunts for hydrocephalus management, neuroendoscopes for improved surgical access and cranial closure products for quick & secure reattachment more…

Catheter tip occluder suppliers

Teleflex Medical www.teleflexmedical.com

Cook Group Incorporated www.cookgroup.com

Medtronic Xomed Surgical Products, Inc www.xomed.com

Lemaitre Vascular, Inc. www.lemaitre.com

Clinical Instruments Intl., Inc. +1-(508)-764-2200

Southbridge, Massachusetts Clinical Instruments Intl., Inc. provides carotid bypass shunt, introducers and detergent reagent. more…

Applied Medical www.appliedmedical.com

Codan Medical Aps www.codan.de

Denmark Codan Medical Aps is a manufacturer of disposable medical transfer systems. Our products include infusion sets, transfusion sets, I.V. accessories, pediatric products, syringes, I.V. pumps and continence care products. more…

Synthetic/biological composite vascular graft suppliers

Datascope Corp. www.datascope.com

Fairfield, New Jersey Datascope Corp. offers intervascular and cardiac assist products. We offer balloon pumps, balloon catheters, sutureless securement devices, vascular grafts and peripheral stents. Our CS300 balloon pump with IntelliSense™ combines fiber-optic speed with automatic in vivo calibration. The result more…

Atrium Medical Corporation www.atriummed.com

Lemaitre Vascular, Inc. www.lemaitre.com

Maquet Inc. www.maquet.com

Wayne, New Jersey Maquet Inc. designs equipment and disposables for cardiac surgery. We provide products for ventilation, perfusion systems, cardiac surgery and cardiopulmonary products. We also produce different types of operating tables and lights. more…

Boston Scientific Corporation www.bostonscientific.com

Terumo Corporation www.terumo.co.jp

Perouse Medical www.perouse.com

Bionova International Pty. Ltd. www.bionova.com.au

VIC, Australia Bionova International Pty. Ltd. manufactures vascular prostheses. Our Omniflow II is a biosynthetic vascular prosthesis fpr peripheral revascularization and arteriovenous access. Our research and testing laboratories are equipped to conduct many specialized evaluations on the physico-chemical charac more…

Valvulotome suppliers

Koven Technology, Inc. www.koven.com

St. Louis, Missouri Koven Technology, Inc offers healthcare products. We are an ISO certified company. Our HD-307 is a versatile bi-directional surgical doppler & has a special single frequency unit created for optimal sound quality in low flow states. Our echosounder ES-102EX is a heavy-duty desktop fetal doppler that more…

Edwards Lifesciences Corporation www.edwards.com

Scanlan International www.scanlaninternational.com

St. Paul, Minnesota Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan® single-use aorta/vein punches have large finger rings for greater control & accuracy and taper more…

Instrumed International, Inc. www.instrumedinc.biz

Schaumburg, Illinois Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, maxillo-facial, neuro/spine, OB/GYN, ophthalmic, orthopedic, plastics and urology. We also carry a b more…

Lemaitre Vascular, Inc. www.lemaitre.com

Uresil, LLC www.uresil.com

Skokie, Illinois Uresil, LLC is a medical device development, manufacturing and distribution company that serves the needs of physicians who perform minimally invasive procedures. Our products are categorized into interventional radiology and surgical products. Some of our products are catheter with locking pigtail, more…

Geister Medizintechnik GmbH www.geister.com

Olympus Imaging Corporation www.olympus.co.jp

Japan Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information systems program. The Evis Lucera upper alimentary canal general-purpose video scope corresponds to n more…

Dimeda Instrumente Gmbh www.dimeda.de

Germany Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list comprises of laryngoscopes, aneurysm vessel clips, saw & power tools, and nasopharyngolaryngoscopes. Our e more…

Guided wires

http://www.neometricsinc.com/technologies.html

Medical Guidewire Expertise from Design Through ManufacturingNeoMetrics Minneapolis, MNare the experts in manufacturing OEM mandrel guide wires and wire-based OEM medical devices. NeoMetrics offers medical guide wires for OEM medical procedures. We specialize in FDA cleared steerable guide wires and nitinol guide wires for OEM medical devices.

Guided Wires MA based

Techdevice Corporation www.techdevice.com

Watertown, Massachusetts Techdevice Corporation manufactures balloons, catheters, coils, ground cores and finished guidewires. We specialize in the development of custom medical balloons. Our balloons are ideal for PTCA and PTA catheters, stent delivery systems, esophageal & endotrachial applications and spine therapies. We more…

Biosphere Medical, Inc. www.biospheremed.com

Rockland, Massachusetts Biosphere Medical, Inc. focuses on applying proprietary microsphere technology to medical applications using embolotherapy techniques. Our core technologies, consisting of patented bio-engineered polymers and manufacturing methods, are used to produce miniature spherical beads with beneficial proper more…

Navilyst Medical, Inc. www.navilystmedical.com

Marlborough, Massachusetts Navilyst Medical, Inc. offers medical devices for vascular access, and for the diagnosis & treatment of vascular disease. Our products are used by various healthcare providers including interventional radiologists, interventional cardiologists, oncologists, surgeons, IV nurses & oncology nurses. We more…

Guidewire Technologies, Inc. guidewiretech.com

Salem, New Hampshire Guidewire Technologies, Inc. offers medical guidewires. Our guidewires come in standard, fixed core, and custom designs. Our capabilities include spring winding, grinding, welding, marking, j-tip forming, and PTFE coating. more…

Angiotech Pharmaceuticals, Inc. www.angiotech.com

Vancouver Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company that discovers, develops, & markets innovative technologies & medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions & acute inj more…

Pace Medical, Inc. www.pacemedicalinc.com

Waltham, Massachusetts Pace Medical, Inc. is involved in designing and marketing a complete line of high-quality temporary cardiac pacing products. Our products include both single and dual-chamber temporary cardiac pacemakers, a dual-chamber pacing analyzer, autoclavable temporary pacemaker extension and surgical cables, more…

Concert Medical www.concertmedical.com

Norwell, Massachusetts Concert Medical provides interventional cardiology products. We offer conductor guidewire family and regional anesthesia products. We provide BSmart™, injection monitor for use in regional anesthesia. It has been designed to provide significant clinical information at a fantastic value. more…

Advanced Biomedical Devices, Inc. (ABD, Inc.) www.abd-inc.com

Andover, Massachusetts Advanced Biomedical Devices, Inc. (ABD, Inc.) provides contract engineering and design. We offer medical grade gas dispenser for balloon inflation with CO2 and CO2 powered injector for thermal dilution. This is useful for filling balloons especially for pediatric and adult procedures, whenever there more…

Radius Medical Technologies, Inc. www.radiusmed.com

Acton, Massachusetts Radius Medical Technologies, Inc. specializes in design, development and marketing of minimally invasive medical devices for treating cardiovascular diseases. Our Expro™ elite snare has a 0.035″ profile that permits delivery through conventional diagnostic or therapeutic catheters elimina more…

Rocket Medical www.rocketmedical.com

Hingham, Massachusetts Rocket Medical deals with products for cardiac and thoracic drainage, ascites drainage, infertility, labor ward, colposcopy, and sterile supplies. Our Rocket® Genesis™ embryo transfer catheter set has a new inner catheter design combined with an ultra smooth tip profile that reduces the ri more…

Boston Scientific Corporation www.bostonscientific.com

Ovalum Ltd. www.ovalum.net

Israel Ovalum Ltd. develops and implements effective and safe solutions for chronic and acute total occlusions in the coronary and peripheral arteries. Based on proprietary shape memory alloy techniques and laser processes we offer systems for minimally-invasive cardiology and interventional radiology fiel more… Ovalum Ltd. develops and implements effective and safe solutions for chronic and acute total occlusions in the coronary and peripheral arteries. Based on proprietary shape memory alloy techniques and laser processes we offer systems for minimally-invasive cardiology and interventional radiology fields. The minimally-invasive solution, the citop™ guidewire system, was created for the treatment of arterial conditions that today require bypass surgery or amputation of the lower limb. Our products citop™ 10 CTO Crossing System is a complete platform for CTO cross-over, traverse™ micro-catheter is a 1.9F (0.025”) micro-catheter for easy penetration & octobooster™ is an extension wire.

Aortic Valve

Cryolife Inc. www.cryolife.com

Kennesaw, Georgia CryoLife® Inc. is a biomedical company that produces low temperature preservation of human tissues for implant. Our CryoLife-O’Brien® stentless aortic porcine valve is made of three non-coronary leaflets & is implanted with a single suture line technique. Our BioGlue® surgical adhesive i more…

Carbomedics Inc. www.carbomedics.com

Austin, Texas Carbomedics Inc. specializes in the development of products for treatment of valvular heart disease. We focus on products used to treat cardiovascular & renal diseases. Our OrbisTM universal aortic and mitral valve have a multipurpose cuff design, which allows for a variety of implantation technique more…

St. Jude Medical, Inc. www.sjm.com

St. Paul, Minnesota St.Jude Medical, Inc. delivers implantable bradycardia, cardiac surgical, electrophysiology, implant cardiac monitors, repair, tachycardia, tissue valves, spinal cord stimulation, patient care network, mechanical valves, cardioverter defibrillators, pacemakers, electrophysiology catheters, vascular more…

Edwards Lifesciences Corporation www.edwards.com

Nucleus Medical Art Inc. www.nucleusinc.com

Kennesaw, Georgia Nucleus Medical Art Inc. creates and/or licenses medical illustrations, medical animations, medical images, anatomical charts, anatomical models and interactive multimedia for educational and commercial use. We maintain a proprietary database of more than 15,000 highly detailed, expert reviewed medi more…

Direct Flow Medical, Inc. www.directflowmedical.com

Santa Rosa, California Direct Flow Medical, Inc. deals with aortic tissue valve prosthesis. Our aortic tissue valve prosthesis provides treatment for cardiac valve insufficiency with a safe and effective percutaneous option. more…

On-X Life Technologies, Inc www.onxlti.com

Austin, Texas On-X Life Technologies, Inc manufactures the On-X® Prosthetic Heart Valve. Our heart valve is a pure carbon bileaflet heart valve prosthesis. The smooth surfaces of pure carbon, a transitional flare at the inlet and sleek interior contours of the valve diminish the principal causes of turbulence more…

ATS Medical, Inc. www.atsmedical.com

Minneapolis, Minnesota ATS Medical, Inc. caters to the requirements of the cardiovascular surgery market, providing life-sustaining solutions for cardiac surgeons and their patients. Our products include ATS Open Pivot® heart valves, ATS 3f® aortic bioprosthesis, ATS simulus® annuloplasty valve repair rings/bands and ATS more…

Shelhigh, Inc. www.shelhigh.com

Sorin Biomedica Cardio S.p.A. www.sorin-cid.com

Via Crescentino, Italy Sorin Biomedica Cardio S.p.A. specializes in the field of high-technology bioengineering. We manufacture heart valves. Our bicarbon slimline valve is designed for supra-annular placement of the whole sewing cuff. Our soprano aortic bioprosthesis is created for a totally supra-annular seating, which more…

Minogue Medical, Inc. www.minogue-med.com

Quebec, Canada Minogue Medical, Inc. is engaged in the production of surgical robot. We offer da Vinci ® surgical robot that enables surgeons to control every aspect of surgery. Our da Vinci ® prostatectomy offers robotic surgery for prostate cancer or robotic prostatectomy. It is a minimally invasive surg more…

Mitral Valve

Carbomedics Inc. www.carbomedics.com

St. Jude Medical, Inc. www.sjm.com

Edwards Lifesciences Corporation www.edwards.com

Nucleus Medical Art Inc. www.nucleusinc.com

On-X Life Technologies, Inc www.onxlti.com

Shelhigh, Inc. www.shelhigh.com

Thomas Medical Products, Inc. www.thomas-medical.com

Malvern, Pennsylvania Thomas Medical Products, Inc. is a medical device manufacturer. We design and develop Class II and Class III single-use devices for OEM customers. We focus on catheter based vascular access and vascular device delivery medical devices for diagnostic and therapeutic procedures in the cardiology, elec more…

Landmark Surgical Ltd www.landmark-surgical.co.uk

Merseyside, United Kingdom Landmark Surgical Ltd supplies a wide range of surgical instruments. We offer a wide range of quality instruments for minimally invasive surgery. Our cardio thoracic instruments include forceps, artery forceps, coronary artery bypass retractors, hand held retractors, bulldog clamps, dilators, corona more…

Sorin Biomedica Cardio S.p.A. www.sorin-cid.com

Kaisers Surgical Instruments Pty Ltd www.kaisers.com.au

Minogue Medical, Inc. www.minogue-med.com

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The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Valves & Tools, tagged Centers for Medicare & Medicaid Services (CMS), Coverage with Evidence Development (CED), FDA, Transcatheter Aortic Valve Replacement on June 19, 2012| 9 Comments »

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED)

Reporter: Aviva Lev-Ari, PhD, RN

Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:

TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA approved indication and when all of the following conditions are met.

The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication.

Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for open aortic valve replacement (AVR) surgery; and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.

The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.  TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to: On-site heart valve surgery program,
Cardiac catheterization lab or hybrid operating room/catheterization lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy, offering quality imaging,
Non-invasive imaging such as echocardiography, vascular ultrasound, computed tomography (CT) and magnetic resonance (MR),
Sufficient space, in a sterile environment, to accommodate necessary equipment for cases with and without complications,
Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
Appropriate volume requirements per the applicable qualifications below.

There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.  Qualifications to begin a TAVR program for hospitals without TAVR experience:

The hospital program must have the following:

≥ 50 total AVRs in the previous year prior to TAVR, including ≥ 10 high-risk patients, and;

≥ 2 physicians with cardiac surgery privileges, and;

≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

Qualifications to begin a TAVR program for heart teams without TAVR experience:

The heart team must include:

Cardiovascular surgeon with:

≥ 100 career AVRs including 10 high-risk patients; or

≥ 25 AVRs in one year; or

≥ 50 AVRs in 2 years; and which include at least 20 AVRs in the last year prior to TAVR initiation; and

Interventional cardiologist with:

Professional experience with 100 structural heart disease procedures lifetime; or;

30 left-sided structural procedures per year of which 60% should be balloon aortic valvuloplasty (BAV). Atrial septal defect and patent foramen ovale closure are not considered left-sided procedures; and

Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers; and

Device-specific training as required by the manufacturer.

Qualifications for hospital programs with TAVR experience:

The hospital program must maintain the following:

≥ 20 AVRs per year or ≥ 40 AVRs every 2 years; and

≥ 2 physicians with cardiac surgery privileges; and

≥ 1000 catheterizations per year, including ≥ 400 percutaneous coronary interventions (PCIs) per year.

Qualifications for heart teams with TAVR experience:

The heart team must include:

A cardiovascular surgeon and an interventional cardiologist whose combined experience maintains the following:

≥ 20 TAVR procedures in the prior year, or;

≥ 40 TAVR procedures in the prior 2 years; and

Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers.

The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56. The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

Stroke;

All cause mortality;

Transient Ischemic Attacks (TIAs);

Major vascular events;

Acute kidney injury;

Repeat aortic valve procedures;

Quality of Life (QoL).

The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):

When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies?

How do outcomes and adverse events in subpopulations compare to patients in the pivotal clinical studies?

What is the long term ( ≥ 5 year) durability of the device?

What are the long term ( ≥ 5 year) outcomes and adverse events?

How do the demographics of registry patients compare to the pivotal studies?

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

TAVR is covered for uses that are not expressly listed as an FDA approved indication when performed within a clinical study that fulfills all of the following. The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.

As a fully-described, written part of its protocol, the clinical research study must critically evaluate not only each patient’s quality of life pre- and post-TAVR (minimum of 1 year), but must also address at least one of the following questions:

What is the incidence of stroke?

What is the rate of all cause mortality?

What is the incidence of transient ischemic attacks (TIAs)?

What is the incidence of major vascular events?

What is the incidence of acute kidney injury?

What is the incidence of repeat aortic valve procedures?

The clinical study must adhere to the following standards of scientific integrity and relevance to the Medicare population:

The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.

The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.

The research study does not unjustifiably duplicate existing studies.

The research study design is appropriate to answer the research question being asked in the study.

The research study is sponsored by an organization or individual capable of executing the proposed study successfully.

The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it also must be in compliance with 21 CFR Parts 50 and 56. In particular, the informed consent includes a straightforward explanation of the reported increased risks of stroke and vascular complications that have been published for TAVR.

All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).

The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed as Medicare coverage requirements.

The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.

The clinical research study is registered on the http://www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.

The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org). However a full report of the outcomes must be made public no later than three (3) years after the end of data collection.

The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.

The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigator’s contact information, to the address below. The information will be reviewed, and approved studies will be identified on the CMS website.

Director, Coverage and Analysis Group

Re: TAVR CED

Centers for Medicare & Medicaid Services (CMS)

7500 Security Blvd., Mail Stop S3-02-01

Baltimore, MD 21244-1850

TAVR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis.

http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257&ver=4&NcaName=Transcatheter+Aortic+Valve+Replacement+(TAVR)&bc=ACAAAAAAIAAA&

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Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Exec Compensation in the Cardiac & Vascular Repair Tools Subsegment, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Uncategorized, Valves & Tools, tagged Aortic valve, Aortic valve stenosis, Cardiac surgery, Edwards Lifesciences Corporation, Edwards SAPIEN, Food and Drug Administration, Heart valve, PARTNER II Clinical Trial, Total stockholder return (TSR), Transcatheter Aortic Valve Replacement (TAVR) on June 19, 2012| 16 Comments »

Curator: Aviva Lev-Ari, PhD, RN

Edwards Lifesciences Corporation, Irvine, California delivers acute hemodynamic monitoring & heart valves. Their new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve diseases. Their embolectomy catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Edwards Lifesciences Reports Strong 2012 Fourth Quarter Results

February 5, 2013

IRVINE, CA, February 04, 2013 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2012, of $91.1 million, or $0.77 per diluted share, compared to net income of $63.1 million, or $0.53 per diluted share, for the same period in 2011.

During the quarter, the company recorded a global realignment pretax charge of $9.0 million, primarily related to severance costs. Additionally, in its non-GAAP results for the quarter, the company included an $8.4 million tax benefit, which represents the portion of the recently renewed Federal research and development (R&D) tax credit that is retroactive to the beginning of 2012. In the quarter ending March 31, 2013, the company will record the 2012 tax credit as required, but will exclude it from non-GAAP results. The impact of these special items was $0.13 per diluted share.

Adjusting for special items from both periods detailed in the reconciliation table below, fourth quarter diluted earnings per share were $0.90, compared to $0.62 in the prior year quarter, an increase of 45.2 percent.

Fourth quarter net sales increased 18.7 percent to $510.5 million compared to the same period last year. Sales growth excluding the impact of foreign exchange was 21.2 percent.

“Our fourth quarter capped a year of significant progress as we introduced our innovative SAPIEN technology to the U.S.,” said Michael A. Mussallem, chairman and CEO. “We are very proud that more than 5,000 patients in the U.S. have been treated with our transcatheter valves since launch, and we are aggressively investing to expand the availability of this important therapy. In spite of a difficult economic environment, underlying(1) sales were up 16 percent in 2012 driven by a strong finish in each of our product lines.”

Sales Results
For the fourth quarter, the company reported Surgical Heart Valve Therapy product group sales of $197.7 million, which included $29.1 million of cardiac surgery systems sales. Sales grew 3.8 percent over the fourth quarter last year, or 5.5 percent excluding the impact of foreign exchange. Growth outside the U.S. was 4.0 percent, or 7.2 percent excluding the impact of foreign exchange, while sales in the U.S. grew 3.5 percent.

Sales of transcatheter heart valves (THV) were $161.0 million for the quarter, a 72.8 percent growth over the fourth quarter last year, or 77.2 percent excluding the impact of foreign exchange. These results were driven by the ongoing U.S. launch of the SAPIEN valve, with total U.S. THV sales of $80.7 million. Outside the U.S., sales grew by 5.5 percent, or 10.0 percent excluding the impact of foreign exchange.

“We continue to expect underlying transcatheter heart valve sales to grow 30 to 45 percent in 2013. This would result in global sales of $710 million to $790 million, which includes $390 million to $440 million of sales in the U.S.,” Mussallem said.

Critical Care product group sales were $151.8 million for the quarter, including vascular sales of $13.8 million. Critical care sales were $138.0 million, representing growth of 3.5 percent, or 6.0 percent excluding the impact of foreign exchange. Growth was driven primarily by advanced monitoring products in Japan and the U.S.

Domestic and international sales for the fourth quarter were $224.9 million and $285.6 million, respectively.

Additional Operating Results
For the quarter, Edwards’ gross profit margin was 75.4 percent, compared to 72.2 percent in the same period last year. This improvement was driven primarily by a more profitable product mix and the impact from foreign exchange.

Selling, general and administrative expenses were $177.9 million for the quarter, or 34.8 percent of sales, compared to $163.4 million, or 38.0 percent of sales, in the same period last year. The increase in expenses was driven primarily by U.S. transcatheter launch-related investments.

Research and development for the quarter grew 23.4 percent to $74.9 million, or 14.7 percent of sales. This increase was the result of additional investments in clinical studies and new product development efforts in all of the company’s product lines.

Free cash flow for the quarter was $70.6 million, defined as cash flow from operating activities of $126.4 million, less capital spending of $55.8 million.

Cash and cash equivalents and short-term investments were $521.4 million at the end of the quarter. Total debt at December 31, 2012, was $189.3 million.

During the quarter, the company repurchased approximately 2.1 million shares of common stock for $186.9 million. At December 31, 2012, approximately $248 million was available for share repurchase under the company’s existing share repurchase authorization.

Twelve-Month Results
For the twelve months ended December 31, 2012, the company recorded net income of $293.2 million, or $2.48 per diluted share, compared to $236.7 million, or $1.98 per diluted share, for the same period in 2011. On a non-GAAP basis, earnings per diluted share were $2.69, compared to $2.02, a 33.2 percent increase.

Net sales for the twelve months of 2012 increased 13.2 percent to $1.90 billion. Underlying sales growth was 16.2 percent.

Domestic and international sales for the twelve months were $812.1million and $1,087.5 million, respectively.

Free cash flow for the year was $253.1 million, defined as cash flow from operating activities of $373.8 million, less capital spending of $120.7 million.

During 2012, the company repurchased approximately 4.0 million shares of common stock for $353.2 million.

Outlook
“We expect another exciting year for Edwards Lifesciences with continued strong sales growth, greater operating leverage, and progress on a number of important clinical milestones,” Mussallem said. “To strengthen our leadership position we plan to continue investing substantially in the development of transcatheter valves and other structural heart disease therapies, as well as in critical care technologies. We believe our focused innovation strategy, together with our global presence and strong financial footing, uniquely position us to drive strong, sustainable growth, while we help treat additional patients.

“We continue to expect full year sales of $2.1 billion to $2.2 billion and earnings per diluted share, excluding special items, of $3.21 to $3.31,” said Mussallem. “For the first quarter 2013, we project total sales of $505 million to $530 million and diluted earnings per share, excluding the $0.07 benefit from the 2012 R&D tax credit and any other special items, between $0.74 and $0.78.”

SOURCE:

http://www.fiercemedicaldevices.com/press-releases/edwards-lifesciences-reports-strong-fourth-quarter-results?utm_medium=nl&utm_source=internal

History of Edwards Lifesciences

Edwards Lifesciences’ roots date to 1958, when Miles “Lowell” Edwards set out to build the first artificial heart.  Edwards was a 60-year-old, recently retired engineer holding 63 patents in an array of industries, with an entrepreneurial spirit and dreams of helping patients with heart disease. His fascination with healing the heart was sparked in his teens, when he suffered through two bouts of rheumatic fever, which can scar heart valves and eventually cause the organ to fail.

With a background in hydraulics and fuel pump operations, Edwards believed the human heart could be mechanized. However, when he presented the concept to Dr. Albert Starr, a young surgeon at the University of Oregon Medical School, the idea was met with hesitation. Instead, Starr encouraged Edwards to focus first on developing an artificial heart valve, for which there was an immediate need.   After only two years, the first Starr-Edwards mitral valve- which is not longer available for sale – was designed, developed, tested, and successfully placed in a patient. Newspapers around the world reported on what they termed a “miraculous” heart surgery.   This innovation spawned a company, Edwards Laboratories, which set up shop in Santa Ana, Calif. — not far from where Edwards Lifesciences’ global headquarters is located today.

Edwards Lifesciences’ heart valve expertise has led to the development of one of the most exciting opportunities in the cardiovascular field – transcatheter heart valve replacement. The specially-designed valve and delivery system* is being evaluated in clinical studies in which high-risk patients receive a valve replacement without traditional open-heart surgery and while their heart continues to beat. Clinicians replace a patient’s aortic valve via a catheter inserted into a small incision in either the leg or between the ribs. Edwards Lifesciences’ leadership in transcatheter heart valve replacement includes a commitment to rigorous scientific study of the procedure and to extensive clinician training and education.  Consistent with this effort to explore less invasive surgery, the company is committed to providing tools for minimally invasive cardiac surgery that allow cardiac surgeons to perform heart valve operations through small openings, or “ports,” in the spaces between the ribs.

http://cardiovascular.eng.uci.edu/edwardslifesciences/history

In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

This study is currently recruiting participants.

Verified May 2012 by Edwards Lifesciences

First Received on March 7, 2011. Last Updated on May 23, 2012 History of Changes

Sponsor:	Edwards Lifesciences
Information provided by (Responsible Party):	Edwards Lifesciences
ClinicalTrials.gov Identifier:	NCT01314313

Purpose

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems: NovaFlex (transfemoral access) and Ascendra2 (transapical access) in patients with symptomatic, calcific, severe aortic stenosis.

Condition	Intervention	Phase
Symptomatic Severe Aortic Stenosis	Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: AVR with a surgical heart valveDevice: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis	Phase 3

Study Type:	Interventional
Study Design:	Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title:	The PARTNER II Trial “Placement of AoRTic TraNscathetER” Valves Trial” (US) [Edwards Study 2010-12]

http://www.clinicaltrials.gov/ct/show/NCT01314313?order=4

Unparalleled Commitment to Research

The research vision for The Edwards Lifesciences Center for Advanced Cardiovascular Technology is a dynamic process and will be developed and implemented by the Center and faculty.

The broad vision will encompass basic research and development of new technologies focused on the treatment of cardiovascular disease.

The breadth of this vision will allow the flexibility to recruit the most outstanding faculty in the cardiovascular field, as well as allow the Center’s research activity to move quickly into new areas while remaining focused in the cardiovascular system. Potential areas of expertise and focus will include, but are not limited to:

Valve replacement technology
Regenerative and degenerative cardiovascular medicine (including tissue engineering and stem cell biology)
Non-invasive (wireless) cardiovascular monitoring, intervention, and imaging
Novel stent or catheter-based therapies including new biological coatings

The engineering expertise that will be applied to these areas include Micro-Electro-Mechanical Systems (MEMS), nanotechnology, biophotonics, biomaterials, systems biology, and computation/modeling.

Core Facilities

The Center has three fully functional core research facilities, and a fourth facility in the final planning stages. The facilities will provide unique and/or synergistic instrumentation and expertise for the campus and community. Access to the core facilities is limited to faculty members who are members of the Center and their trainees. The core facilities are briefly described below, and more information about the instrumentation, access, training, and reservations can be found on each facility’s page:

1. Surgical and Imaging Facility (SIF). The SIF is currently in a planning stage. This facility could potentially provide a major resource to the campus, not only for cardiovascular research, but other organ systems that need small and large animal models, as well as training opportunities for UC Irvine and community-based cardiologists, scientists, or sales representatives from local companies. The planned facility will include the following functionalities:

Complete catheterization including hemodynamic monitoring with bi-plane fluoroscopic imaging

Ultrasound

MicroCT

MicroPET (positron emission tomography)

MicroSPECT (single positron emission computed tomography)

OCT (optical computed tomography)

In addition to the catheterization lab, a fully functional operating room for both acute and chronic procedures are planned.

2. Cell and Tissue Facility (CTF). The Cell and Tissue Facility, located in Engineering Hall rooms 2110 and 2128, is a complete cell-culturing facility. The center offers six biosafety cabinets, two water baths, six CO2 incubators – including one for oxygen tension control – two benchtop incubators – including one for oxygen tension control – centrifuges with refrigeration capabilities, three cell culture microscopes, refrigeration, -80C and -20C freezers, liquid nitrogen storage, and a purified water source.

3. Mechanical Testing Facility (MTF). This core facility provides two basic instruments for investigating mechanical properties. The Synergie 100 system performs tension or compression testing, while the rheometer provides the capability to study dynamic and shear properties. The instruments are housed in Engineering Hall room 2115.

4. Microscopy Core Facility (MCF). Microscopy Core Facility has multiple imaging capabilities, including confocal, fluorescence, differential interference contrast, phase contrast, darkfield, and brightfield microscopy. This core facility is equipped with a Nikon Eclipse TE300 Inverted Scope with Nikon PCM2000 Confocal Attachment, an Inverted Eclipse TE300, and an Upright Eclipse E800 w/ VFM epi-fluorescence attachment. Each microscopy is equipped with a 12-bit CCD camera; specifications can be found on the facility’s website.

http://cardiovascular.eng.uci.edu/book/export/html/12

Executive Compensation in the Cardiology and Cardiac Surgery Medical Devices Market: Comparison of Edwards Lifesciences Corporation with other Suppliers – Analysis of the SAPIEN Contribution

Edwards Lifesciences Corporation

NOTICE OF 2012 ANNUAL MEETING OF STOCKHOLDERS

To be held on Thursday, May 10, 2012

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

Definition of a Comparator Group for Determination of Executive Compensation. Edwards Lifesciences 2011 Comparator Group include:

Allergan, Inc.

Masimo Corp.

Becton Dickinson & Co.

Medtronic, Inc.

Boston Scientific Corp.

PerkinElmer, Inc.

C. R. Bard, Inc.

ResMed, Inc.

CareFusion, Inc.

St. Jude Medical, Inc.

Covidien plc

Stryker Corp.

Gen-Probe, Inc.

Thoratec Corp.

Hospira, Inc.

Varian Medical Systems, Inc.

Illumina, Inc.

Zimmer Holdings, Inc.

Integra Lifesciences Holding Corp.

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

p.28

In the Chairman of the board address: 2011 Performance was Strong. The year 2011 was one of significant investment and major milestones. Successful PARTNER trial results culminated in U.S. regulatory approval to begin commercially offering the SAPIEN transcatheter heart valve to many inoperable patients. We developed a rigorous training program to promote the teamwork of cardiac surgeons and interventional cardiologists, and to emphasize excellent clinicalresults. To support expected growth, we expanded our heart valve manufacturing capacity, and made additional enhancements to our infrastructure, including our information and quality systems.As a result of the combined efforts of our management team and their employees, in 2011, theCompany delivered another year of strong financial performance. The company-wide financial measures usedto determine 2011 incentive compensation consisted of goals for revenue growth, net income, and free cashflow.

The following table shows the 2011 results for these three metrics compared against the 2011 targets and the comparable performance measures for 2010 and 2009:

2011 2011 2010 2009

Actual Target Actual Actual

Revenue Growth* . . . . . . . . . . . . . . . . . . . . . 11.0%** 11.4%** 12.7% 11.4%

Net Income* . . . . . . . . . . . . . . . . . . . . . . . . $259.6** $244.0** $218.9 $181.5

Free Cash Flow* . . . . . . . . . . . . . . . . . . . . . $215.0** $215.0** $196.2 $178.1

http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf

p.25

	Comparison of Cumulative Five Year Total Stock Return
	2007	2008	2009	2010	2011
Edwards Life Sciences	98	117	185	344	301
S&P	104	64	79	89	89
Morgan Stanley Health Care Products	103	82	102	109	115
http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.26

Pay for Performance Philosophy.The Compensation Committee strongly believes that executive compensation should be tied to performance and strives to create a pay for performance culture. Our compensation objectives are to offer programs that emphasize performance-based compensation and align the financial interests of our executives with those of the Company’s stockholders. Accordingly, approximately 80% of the total direct compensation of our Chairman of the Board and Chief Executive Officer (the ‘‘Chairman and CEO’’) and our Named Executive Officers is at risk based upon the performance of the Company. p.26

Company	CEO TDC (Average) (in thousands)
Company	Most Recent FY	Last 3 FYs	Last 5 FYs
2011 Comparatoe Group
90th Percentile	$10,627	$11,110	$10,398
75th Percentile	$9,590	$10,012	$9,143
Median	$7,839	$7,748	$7,836
25th Percentile	$5,011	$5,008	$5,228
Edwadrs Lifesciences	$5,829	$5,789	$5,567
Percentile	36.60%	33.90%	26.60%
http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.29

When compared to the competitive data based on the 2011 Comparator Group, the average base salary compensation paid to the Named Executive Officers for the 2011 fiscal year was approximately 2.5% below the median, the total cash compensation was at the median, and total direct compensation was approximately at the median. The following chart illustrates the total direct compensation of our Chairman and CEO.

The total stockholder return (TSR) for the Company’s common stock for the previous one, three, and five years, compared to the data of our 2011 Comparator Group:

2011 Edwards Most Recent Return: -11.8%, 42 percentile

Last 3 FYs 55.6%, maximum percentile

Last 5 FYs 37.3%, maximum percentile

2011 Comparator Group: 90^th percentile subgroup, Most Recent TSR 7.6%

Last 3 FYs 18.9%

Last 5 FYs 8.5%

Executive compensation at Edwards in 2012 will increase significantly as a direct results from the Edwards’ stock soars after FDA panel nod on expanded Sapien valve use

On June 14, 2012:

Stock Price and Trading Volume 7/2011 to 6/14/2012

http://www.dailyfinance.com/quote/nyse/edwards-lifesciences-corp/ew/charts

Stock Price and Trading Volume 5/21/2012 to 6/14/2012

http://www.dailyfinance.com/quote/nyse/edwards-lifesciences-corp/ew/charts

Edwards Lifesciences Corp. (EW) won the backing of U.S. advisers for an expanded use of the company’s Sapien heart valve as an alternative to open-heart surgery. Edwards’ transcatheter aortic heart valve may soon have two indications: for aortic stenosis patients who are both inoperable and at high risk for surgery.

Smith, PARTNER trial’s principal investigator of Cohort A during the sponsor presentation, urged that the higher frequency of neurological events that occurred within the TAVR group should not be “trivialized” in either treatment group. Smith called aortic stenosis “one of the conditions we understand best in cardiovascular disease.” He called transcatheter aortic valve replacement (TAVR) a “miracle therapy,” and said that outcomes for the procedure will only continue to improve. And while most of the day’s conversation gave kudos to the PARTNER trial and its findings, concerns did focus on gender differences and neurological events.

Mark Hollmer explains that Edwards Lifesciences ($EW) scored a major win on Wednesday, successfully making its case before an FDA panel of experts that its Sapien transcatheter heart valve should be used in a broader class of patients. The agency’s Circulatory Systems Advisory Committee voted 11-0 (one panelist abstained) that the benefits outweighed any risks in using the valve for patients with severe aortic stenosis who are high-risk but could otherwise undergo surgery.

Investors reacted favorably, driving Edwards’ stock up more than 8% to $98.55 by midday on June 14. Bloomberg, MedPage Today, The Associated Press, CardiovascularBusiness and many others covered the day-long panel meeting and final vote. While the FDA doesn’t have to follow the panel’s recommendation, it usually does. Panel members also voted 12-0 that Sapien is effective and 10-2 that the valve is safe.

When the FDA comes out with its final decision is anyone’s guess, but Bloomberg predicts final action could come in October, based on the timeline for Sapien’s initial approval in 2011 (panel meeting in July; regulatory approval in November). Sapien initially gained FDA approval for patients with limited classes of stenosis who can’t have surgery.

To make its case during the 8-hour-plus hearing, Edwards Life Sciences relied on the “Cohort B” part of its pivotal PARTNER trial, which compared transcatheter aortic valve implantation (TAVI) with surgery. (“Cohort A” was used for the initial approval in November.) PARTNER recruited 699 high-risk older patients with severe aortic stenosis and randomly assigned them to TAVI (n=348) or surgery. About two-thirds of the TAVI patients underwent transfemoral procedures, where the device was threaded through the femoral artery, while 103 had transapical access procedures, where the device was inserted directly into the tip of the left ventricle of the heart.

Death rates were essentially the same at 1 year for the Sapien group and the control group. When divided up by type of valve implantation compared with matched surgery controls, the death rate for Sapien implanted via a transfemoral approach was 24.2% versus 26.8% for surgery; and for the transapical approach the 1-year mortality rate was 22.2% for the Sapien group and 26.4% for the open-heart surgery group. Although the death rate was very similar, TAVI patients had double the rate of stoke during the 30-day period following the procedure. With the transapical approach, there appeared to be an even greater increased risk for early stroke, which the panel chalked up to the fact that patients who received TAVI via transapical approach were sicker patients, so their outcomes were poorer than those who were implanted via a transfemoral approach.

The trial involved 699 older patients of high risk with severe aortic stenosis who were randomly assigned to the TAVI procedure or surgery. Among the findings: the death rate was similar for both, but patients who had transcatheter aortic valve implantation faced double the rate of stroke over the initial 30-day period after the surgery. That finding concerned both FDA scientists and panel members, though Edwards countered that stroke rates evened out after another year, Bloomberg notes. Regulators in advance of the hearing were also bothered by how the company chose patients and categorized them for the trial, arguing that it constituted bias to some degree, and potentially skewed the results.

Edwards wants to do a post-approval study to follow patients from the trial and also create a registry to enroll new patients. FDA staff members agree, and urged at least 5 years of follow-up for subjects from the trial.

http://www.fiercemedicaldevices.com/story/edwards-lifesciences-argue-expanded-sapien-valve-use/2012-06-12?utm_medium=nl&utm_source=internal

http://www.medpagetoday.com/Cardiology/PCI/33263

Transcatheter Heart Valve Replacement Market: A Market of $2.5 Billion in the US

The market for transcatheter valves may total $2.5 billion in the U.S., said Jason Mills, a San Francisco-based analyst with Canaccord Adams Inc. The initial FDA approval of Sapien in November boosted Edwards’s sales 67 percent in the first quarter to $122 million, Michael Mussallem, the company’s chairman and chief executive officer, said in an April 24 earnings call.

The device is meant to treat aortic stenosis. The debilitating condition is caused by a narrowing valve that restricts the ability of blood to enter the aorta, the main artery that carries blood from the heart, according to the National Institutes of Health.

“A broader indication for high-risk patients would enable multidisciplinary heart teams to choose the approach best suited to their patients’ needs,” Mussallem said in a statement after the panel’s vote. “We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis.”

The FDA may decide on approval in October if reviewers follow the same timeline they did when they cleared the valve for inoperable patients. Advisers met in July to consider the device for inoperable patients and approved it in November.

http://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=34321:sapien-makes-more-headway-in-aortic-stenosis-world

Another point of concern, as Bloomberg points out: FDA staff noted that patients treated with Sapien faced twice the stroke risk in the initial month after the implant procedure, compared to patients who had open-heart surgery instead.

The FDA wants the company to commit to a long-term follow up, post-approval study that tracks patients for at least 5 years to address its concerns. Edwards appears to be on the same page, having proposed a post-approval study that would follow patients from its pivotal trial, as well as a new patient registry, according to the story.

http://www.fiercemedicaldevices.com/story/edwards-lifesciences-argue-expanded-sapien-valve-use/2012-06-12?utm_medium=nl&utm_source=internal

Edwards won a PMA for the Sapien device for inoperable patients with aortic stenosis, a hardening and narrowing of the aortic valve, in November 2011.* FDA reviewers said the arm of the study covering the high-risk patients may have been flawed by the inconsistencies.

“FDA notes that screening and subsequent enrollment practices were not homogenous. The large variation between the ratios of those screened to those enrolled may represent different selection criteria among sites,” according to documents released ahead of the meeting scheduled for Wednesday. “Enrollment practices related to identification of ‘inoperable’ and ‘high risk’ patients were not homogenous across sites.”

https://www.massdevice.com/news/fda-possible-selection-bias-issues-confound-edwards-sapien-study

FDA Panel

There was “no significant difference” in mortality between patients treated with surgery vs. treatment with the Sapien valve, according to the documents. But some patients who were slated for traditional open heart surgery were treated with the TAVI device, and vice-versa, making it difficult to evaluate the study’s endpoints.

“[T]he issue of [surgery] patients not receiving [surgery], [Sapien] patients receiving [surgery], and [surgery] patients undergoing concomitant operations makes evaluation of these endpoint results difficult,” according to the FDA reviewers. “Although the primary endpoint was met, issues related to potential selection bias confound the interpretation of these results.”

“We believe the Partner trial was well-designed and executed. We are proud of the efforts of the leading heart teams that supported this ground-breaking trial and what it means for patients,” an Edwards spokeswoman told MassDevice.com via email. “We are reserving further comment on this or related matters until the Advisory Committee scheduled for June 13.”

The FDA also wants the circulatory devices panel to consider better ways to construct future trials of similar devices and to come up with appropriate endpoints for a post-market surveillance study. The panel is scheduled to vote on whether the device is as safe and effective as surgery and whether its benefits outweigh its risks for the high-risk cohort.

https://www.massdevice.com/news/fda-possible-selection-bias-issues-confound-edwards-sapien-study?page=2

Medicare to Cover Edwards’ Sapien Heart Valve

On May 2, 2012 Mark Hollmer reported that for medical device companies, gaining Medicare reimbursement for surgical procedures involving their implants can be a sort of financial holy grail. After all, an implant won’t be used much if the cost can’t be covered. Edwards Lifesciences ($EW) has reached that point now that the Centers for Medicare & Medicaid Services has agreed to pay for surgery involving its Sapien transcatheter heart valve. Ssince Sapien’s U.S. debut in November. As a result, sales should get a boost, Wells Fargo analyst Larry Biegelsen said, as quoted by Bloomberg in its coverage of the news.

Specifically, CMS approved reimbursement of transcatheter aortic valve replacement therapy when the device is used to treat symptomatic aortic valve stenosis. The coverage determination is flexible and authorizes current and future FDA approved indications, the company notes, as well as coverage for clinical studies.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA. Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve. In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

http://www.mercurynews.com/business/ci_20850361/fda-panel-backs-broader-use-edwards-heart-valve

eBook: Waiting for Guidelines Will FDA take the reins of laboratory-developed tests?

Two cardiac surgeons must independently evaluate the patient first, and hospitals offering the procedure must have an on-site heart valve surgery program, plus a cardiac catheterization lab or a lab/operating room hybrid with appropriate imaging systems. And as Bloomberg points out, the guidelines limit who can conduct the procedure to a multidisciplinary team of doctors that must include at least one heart surgeon and interventional cardiologist. And those experts must perform the surgery at least 20 times annually to remain certified.

CMS also requires the heart team and hospital to take part in a post-surgery clinical trial, a national registry that follows patients who have the procedure for at least one year. This study will look at variables including strokes, death, heart attacks, kidney injuries, any repeat procedures and overall quality of life.

Sapien, generated $41 million in sales during the first quarter, the first full quarter the device has been on the market.

http://www.fiercemedicaldevices.com/story/medicare-cover-edwards-sapien-heart-valve/2012-05-02?utm_medium=nl&utm_source=internal

June 13, 2012 – FDA panel votes in favor of Sapien valve. The FDA’s Circulatory System Devices Committee gave Edwards Lifesciences ($EW) a win Wednesday with a vote recommending the devicemaker’s Sapien transcatheter heart valve after an epic session. The panel voted 9-0–with one member abstaining–that the device’s benefits outweighed its risks, 7-3 in favor of its safety, and 9-1 for its effectiveness. The FDA will make a decision on the valve at a later date.

Earlier in the week, the FDA released a report showing the valve, which can be implanted without major surgery, significantly reduced death rates versus standard therapy in people with severe aortic stenosis. However, there was a higher incidence of major strokes and major vascular events seen in the group receiving the Sapien valve in a study.

Indeed, neurological events represented a major issue in the meeting, as heartwire notes, with several panel members pointing out that older, frail patients are far more concerned about strokes than death. Furthermore, mortality reduction with TAVI is, as the FDA terms it, impressive, but most treated patients die within two years. That said, panel members concluded that the benefits of transcatheter valve replacement in these frail patients offset the stroke risk.

“We are pleased with the panel’s strong recommendation for approval, and would like to thank them for their comprehensive and thoughtful review of the data presented from The PARTNER Trial. This represents another important step on the path to what we hope will lead to FDA approval of SAPIEN,” Michael Mussallem, Edwards’ chairman and CEO, says in a statement. “We would also like to thank the principal investigators and their heart teams at the PARTNER hospitals for their dedication to this clinical trial, and to their patients for participating in a study of a new therapy.”

Edwards has marketed Sapien in Europe since 2007 and could start selling it in the U.S. in Q4, 2012. Analysts note the worldwide market for heart valves could ultimately grow to $2 billion in annual sales, as the Orange County Business Journal reports.

http://www.fiercemedicaldevices.com/story/fda-panel-votes-favor-sapien-valve/2011-07-20

The valve SAPIEN is currently approved for patients who aren’t healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades. On June 13, 2012 – the implant is approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes per FDA panel on June 13, 2012.

Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)

The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions described in

http://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

CONCLUSIONS

The Pay for Performance Philosophy at Edwards Lifesciences will support a substantial reward for the Chairman and CEO in 2012. His $5.8 Million in total compensation in 2011, occurred for a average of Five Year Total Stockholders Return of 301% while at the same time S&P delivered an anemic Five Year Total Stock Return of 89% per 2011 Edwards Most Recent Return: -11.8%, 42 percentile as reported in 2011 Edwards Annual Report. With the potential of EW symbol exceeding $100 per share in the second half of 2012, CEOs total compensation may move Edwards from the 36 percentile to the median in the Comparator Group selected for determination of Executive compensation at Edwards. . In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

FDA’s broadening definition of patients eligible for TAVR to include other patients than the ones with aortic stenosis that can’t undergo open heart surgery, will have an immediate effect on the total cost that these procedures will bear by having the procedure been covered by Medicare and Medicaid. An increase in the Healthcare cost and its National burden is expected. Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

The Procedure will have a major improvement in the quality of life of patients undergoing TAVR with a favorable impact on their longevity.

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