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FDA Approval for Under-Skin Defibrillator goes to Boston Scientific Corporation

Posted in 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 Law & Patient Safety, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Technology Transfer: Biotech and Pharmaceutical, tagged Boston Scientific, Defibrillation, Food and Drug Administration, ICD System, Implantable cardioverter-defibrillator, Ohio State University, Securities Act of 1933, Securities Exchange Act of 1934 on October 1, 2012| Leave a Comment »

FDA Approval for Under-Skin Defibrillator goes to Boston Scientific Corporation

Reporter: Aviva Lev-Ari, PhD, RN

Boston Scientific Corporation (BSX) Wins FDA Approval for Under-Skin Defibrillator

10/1/2012 7:09:13 AM

NATICK, Mass., Sept. 28, 2012 /PRNewswire/ — The U.S. Food and Drug Administration has granted Boston Scientific Corporation (NYSE: BSX) regulatory approval for its S-ICD^® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for thin, insulated wires — known as electrodes or ‘leads’ — to be placed into the heart. This leaves the heart and blood vessels untouched, offering patients an alternative to transvenous implantable cardioverter defibrillators (ICDs), which require leads to be placed in the heart itself.

“The S-ICD System establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy,” said Raul Weiss, M.D., Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University. “Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart.”

Approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients at risk of SCA. The S-ICD System met the primary endpoints of the study, and results were presented earlier this year at the Heart Rhythm Society 33rd Annual Scientific Sessions. The study results support that the S-ICD System is an important new treatment option for a wide range of primary and secondary prevention patients.

“With the addition of the S-ICD System, we believe Boston Scientific has a compelling and highly differentiated portfolio that will help fuel our growth strategy,” said Hank Kucheman, chief executive officer, Boston Scientific. “We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years. The S-ICD System, coupled with our numerous recent regulatory approvals and our other innovative products, such as the WATCHMAN^® Left Atrial Appendage Closure Device and Alair^®Bronchial Thermoplasty System for the treatment of severe asthma, demonstrates our continued commitment to developing and bringing to market innovative products for physicians and their patients.”

Sudden cardiac arrest is an abrupt loss of heart function. Most episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation. Recent estimates show that approximately 850,000 people in the United States are at risk of SCA and indicated for an ICD device, but remain unprotected.

“Each year, thousands of patients indicated for an ICD are not referred to a specialist and remain untreated,” said William T. Abraham, MD, FACC, Director, Division of Cardiovascular Medicine at The Ohio State University Heart Center. “The S-ICD System is an important new treatment option that has the potential to improve patient acceptance of ICD therapy.”

The S-ICD System is designed to provide the same protection from sudden cardiac arrest as transvenous ICDs. The system has two main components: (1) the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed, and (2) the electrode, which enables the device to sense the cardiac rhythm and deliver shocks when necessary. Both components are implanted just under the skinthe generator at the side of the chest, and the electrode beside the breastbone. Unlike transvenous ICDs, the heart and blood vessels remain untouched. Implantation with the S-ICD System is straightforward using anatomical landmarks, without the need for fluoroscopy (an x-ray procedure that makes it possible to see internal organs in motion). Fluoroscopy is required for implanting the leads attached to transvenous ICD systems.

Boston Scientific expects to begin a phased launch of the S-ICD System that will expand over time as medical professionals are trained on the safe and effective use of the system. The company acquired the S-ICD System earlier this year when it completed the acquisition of Cameron Health, Inc. The S-ICD System received CE Mark in 2009 and is commercially available in many countries in Europe as well as in New Zealand. To date, more than 1,400 devices have been implanted in patients around the world. To download a high-resolution image of the S-ICD System go to: http://bostonscientific.mediaroom.com/home.

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The WATCHMAN device is an investigational device in the United States. It is limited by applicable law to investigational use and not available for sale.

About Boston Scientific Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and growth strategy, markets for our products, regulatory approvals, the importance of the S-ICD System, our technology, clinical trials, product launches, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement, legal and regulatory conditions; clinical trials and outcomes; new product introductions; product performance; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. Such factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACT:	Denise Kaigler
	508-650-8330 (office)
	Media Relations
	Boston Scientific Corporation
	denise.kaigler@bsci.com

	Michael Campbell
	508-650-8023 (office)
	Investor Relations
	Boston Scientific Corporation
	investor_relations@bsci.com

SOURCE Boston Scientific Corporation

www.bostonscientific.com

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Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories

Posted in 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, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Health Law & Patient Safety, HTN, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, PCI, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Stents & Tools, Technology Transfer: Biotech and Pharmaceutical, tagged Abbott Laboratories, Absorb™ Bioresorbable Vascular Scaffold, Coronary artery disease, Coronary circulation, Drug-eluting stent, PR Newswire on September 29, 2012| 6 Comments »

Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories

Reporter: Aviva Lev-Ari, PhD, RN

Abbott Laboratories (ABT) Announces International Launch of the Absorb™ Bioresorbable Vascular Scaffold

9/25/2012 10:26:30 AM

ABBOTT PARK, Ill., Sept. 25, 2012 /PRNewswire/ — Abbott (NYSE: ABT) announced today that Absorb, the world’s first drug eluting bioresorbable vascular scaffold (BVS), is now widely available across Europe and parts of Asia Pacific and Latin America. Absorb is a first-of-its-kind device for the treatment of coronary artery disease (CAD). It works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the body, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

The potential long-term benefits of a scaffold that dissolves are significant. The vessel may expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising; treatment and diagnostic options are broadened; the need for long-term treatment with anti-clotting medications may be reduced; and future interventions would be unobstructed by a permanent implant.

“This innovation represents a true paradigm shift in how we treat coronary artery disease. With the launch of Absorb, a scaffold that disappears after doing its job is no longer a dream, but a reality,” said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. “Patients are excited about Absorb since it may allow blood vessels to return to a more natural state and expand long-term diagnostic and treatment options.”

The international launch of Absorb is supported by a robust clinical trial program that encompasses five studies in more than 20 countries around the world. Study data indicate that Absorb performs similar to a best-in-class drug eluting stent across traditional measures such as major adverse cardiovascular events (MACE) and target lesion revascularization (TLR), while providing patients with the added benefits associated with a device that dissolves over time. As the Absorb scaffold dissolves, vascular function is potentially restored to the blood vessel, allowing more blood to flow through the vessel as the body requires.

“Absorb is a leading example of Abbott’s dedication to advancing patient outcomes through innovative technology. Abbott has remained committed to meeting the growing physician and patient demand for a bioresorbable vascular scaffold from the initial device developed nearly 10 years ago to the expansion of our manufacturing capabilities to support this international launch,” said John M. Capek, executive vice president, Medical Devices, Abbott. “We are proud to be the first company to commercialize a drug eluting bioresorbable vascular scaffold, which has the potential to revolutionize the way physicians treat their patients with coronary artery disease.”

Heart disease is the leading cause of death for men and women around the world, and CAD is the most common type of heart disease.^1,2 CAD occurs when arteries that supply blood to the heart become narrowed or blocked, leading to chest pain or shortness of breath and increased risk of heart attack.

About the Absorb Bioresorbable Vascular Scaffold

Absorb is now available in a broad size matrix to support the needs of physicians treating patients with CAD.

The Absorb bioresorbable vascular scaffold, similar to a small mesh tube, is designed to open a blocked heart vessel and restore blood flow to the heart. Absorb is referred to as a scaffold to indicate that it is a temporary structure, unlike a stent, which is a permanent implant. The scaffold provides support to the vessel until the artery can stay open on its own, and then dissolves naturally. Absorb leaves patients with a vessel free of a permanent metallic stent and may allow the vessel to resume more natural function and movement, enabling long-term benefits.^3,4

Abbott’s BVS delivers everolimus, an anti-proliferative drug used in Abbott’s XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

Absorb is neither approved nor authorized for sale and currently is in development with no regulatory status in the United States. Absorb is authorized for sale in CE Mark countries. Absorb is now available in Europe, the Middle East, parts of Asia Pacific, including Hong Kong, Singapore, Malaysia and New Zealand, and parts of Latin America.

About Abbott Vascular

Abbott Vascular is the world’s leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the company’s Web site at www.abbott.com.

¹The top 10 causes of death, World Health Organization. June 2011 Available at: http://www.who.int/mediacentre/factsheets/fs310/en/index.html² Coronary Artery Disease. National Heart, Lung and Blood Institute. May 2011 Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/cad/³Absorb completely dissolves except for two pairs of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.⁴Early evidence indicates natural vessel function is possible to achieve improved long term outcomes. Absorb is a trademark of the Abbott Group of Companies.

On this Scientific Web Site the, Cardiovascular Medical Devices are addressed in the following posts:

Lev-Ari, A. (2012U). Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

http://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Lev-Ari, A. (2012R). Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents http://pharmaceuticalintelligence.com/2012/08/13/coronary-artery-disease-medical-devices-solutions-from-first-in-man-stent-implantation-via-medical-ethical-dilemmas-to-drug-eluting-stents/

Lev-Ari, A. (2012K). Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

http://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

Lev-Ari, A. (2012C). Treatment of Refractory Hypertension via Percutaneous Renal Denervation

http://pharmaceuticalintelligence.com/2012/06/13/treatment-of-refractory-hypertension-via-percutaneous-renal-denervation/

Lev-Ari, A. (2012D). 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)

http://pharmaceuticalintelligence.com/2012/06/22/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/

Lev-Ari, A. (2012E). 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/

Lev-Ari, A. (2012F). 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

http://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

Lev-Ari, A. (2012G). Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

http://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

SOURCE Abbott

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Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa

Posted in Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, tagged Articulating Single-Use Loading Units, COV, Duet TRS, Food and Drug Administration, SULU on August 22, 2012| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa

8/22/2012 8:00:30 AM

MANSFIELD, Mass.–(BUSINESS WIRE)– Covidien today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU). In addition, the Company has discontinued manufacturing the Duet TRS Universal Straight and Articulating SULU.

Covidien has received one report that links the Duet TRS tissue reinforcement material to a post-operative injury after abdominal surgery. The Company has concluded that Duet TRS may have the potential to injure adjacent anatomical structures, which may result in life threatening post-operative complications. This voluntary recall is in addition to the recall announced January 16, 2012, relating to the contraindication of the device in the thoracic cavity. At that time, Covidien received reports of 13 serious injuries and 3 fatalities following the application of Duet TRS in the thoracic cavity.

The affected product codes and descriptions are as follows:

DUET4535 Duet TRS 45 3.5MM STRAIGHT SULU

DUET4535A Duet TRS 45 3.5MM ARTICULATING

SULU DUET4548 Duet TRS 45 4.8MM STRAIGHT SULU

DUET4548A Duet TRS 45 4.8MM ARTICULATING

SULU DUET6035 Duet TRS 60 3.5MM STRAIGHT SULU

DUET6035A Duet TRS 60 3.5MM ARTICULATING

SULU DUET6048 Duet TRS 60 4.8MM STRAIGHT SULU

DUET6048A Duet TRS 60 4.8MM ARTICULATING SULU

Launched in 2009, the Duet TRS reload is a SULU with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 540,000 units worldwide.

http://www.devicespace.com/news_story.aspx?NewsEntityId=270735

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Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

Posted in Bio Instrumentation in Experimental Life Sciences Research, BioSimilars, Cardiac & Vascular Repair Tools Subsegment, Cardiovascular Pharmacogenomics, Cell Biology, Signaling & Cell Circuits, Chemical Genetics, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, HTN, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Nitric Oxide in Health and Disease, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Scientist: Career considerations, Stents & Tools, Systemic Inflammatory Response Related Disorders, Technology Transfer: Biotech and Pharmaceutical, tagged CAD, Coronary stent, Drug-eluting stents, Medical Ethics on August 13, 2012| 30 Comments »

Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

Author: Aviva Lev-Ari, PhD, RN

Real medical ethical dilemmas involved in physician assignment of patients to participate in Clinical Trials

Randomized controlled clinical trials have become the method of choice or the standard technique for obtaining scientific information to be used in changing diagnostic or therapeutic methods. The use of this technique creates an ethical dilemma (Hellman and Hellman, 1991).

Physicians using a randomized clinical trial are cast in two opposing roles at the same time: clinicians and researchers. As clinicians, they have an ethical commitment to individual patients: to practice professionally in an empathetic profession that is concerned with each patient as an individual. By entering into a relationship with an individual patient, the physician assumes obligations and commitments to act always in the patient’s best interest, derived from values of loyalty and the virtue of fidelity to his/her patients. Modifications of these relationships, otherwise dyadic relationship, occurs when a physician assumes legal obligations to report wounds of a suspicious nature and certain infectious diseases. Such obligations do not conflict with the physician’s ethical obligation to act in the best medical interests of his/her patient. Social concerns have pre-empted physician reporting of disease manifestations which are suspected to have public health bearing (Hellman and Hellman, 1991).

The other role assumed by a physician participating in randomized clinical trials, is that of a scientific researcher, committed to determine the validity of formally constructed hypotheses and their testing. Results of scientifically formulated studies using the methods developed in experimental design, derived from the disciplines of Statistics and Operations Research, are presumed to benefit humanity in general, and not only the individual patient participating in such a formally designed clinical trial. The goals of randomized clinical trials were stated by the Director of the National Institute of Allergy and Infectious Diseases, in these words: “It’s not to deliver therapy. It’s to answer a scientific question so that the drug can be available for everybody once you’ve established safety and efficacy” (as cited in Hellman and Hellman, 1991).

How do randomized clinical trials conflict with a physician’s duty towards his/her individual patients? It is a conflict between rights-based Moral Theories on one hand and Utilitarian Theory on the other. Moral theories by Immanuel Kant and John Rowls assert that human beings, by virtue of their unique capacity for rational thinking, are bearers of dignity and ought to be treated as ends in themselves not as means to an end. In contrast, Utilitarianism by Stuart Mills defines what is right as the greatest good for the greatest number, known as social utility (Hellman and Hellman, 1991). Pleasures among them, health and well-being, need be counterbalanced by pain. The morally correct act is the act that produces the most pleasure and the least pain overall. Respectively, believers in Moral theory oppose conduct and self participation in randomized clinical trials, while believers in Utilitarianism support them in earnest.

However, since the distribution of pleasure and pain does have moral consequences, physicians must care about that distribution, since they enter into relationships with many patients. They can’t be indifferent to whether it is these patients or others that suffer for the general benefit of society, even though society might gain from the suffering of a few, even if the physician believes that the suffering by a few is worth the benefit to society. The doctor-patient relationship requires doctors to see their patients as bearers of rights who cannot be merely used for the greater good of humanity.

Consider a new agent that promises more effectiveness of treatment. The control group must be given either an unsatisfactory treatment or a placebo. Even though the therapeutic value of the new agent is unproven, if physicians think it has promise, are they acting in the best interest of their patients in allowing them to be randomly assigned to the control group?

Ethical validity of the assignment of patients to randomized clinical trials involves the following three matters in medical ethics (Hellman and Hellman, 1991, Markman, 1992):

If the physician has no opinion about whether the new treatment is acceptable, then random assignment is ethically acceptable. Lack of enthusiasm does not lore patients to participate or support the merit of conducting the study anyway. Treatment may show promise of beneficial results but also present undesirable complications (Markman paraphrased)
Physician believes that the severity and likelihood of harm and good are evenly balanced, randomization may be ethically acceptable. If the physician has no preference for either treatment, he or she are in a state of equipoise (Freedman, 1992), then randomization is acceptable.
If the physician believes that the new treatment may be either more or less successful or more or less toxic, the use of randomization is NOT consistent with fidelity to the patient.

After patient assignment to a Clinical Trial — What are the risks involved in participation in First-In-Man Stent Implantation as a treatment for cardiovascular diseases?

Dr. R. Stack, professor emeritus of medicine at Duke University, Durham, NC, and president of Synecor, a company developing Bioabsorbable stent, traced the evolution of interventional cardiology from inflation of the first angioplasty balloon to implantation of the first Bioabsorbable stent, in a Founders’ Lecture entitled, “How Can You Get Out of a Full-Metal Jacket?” at the Society for Cardiovascular Angiography and Interventions (SCAI), 29th Annual Scientific Sessions in Chicago, May, 2006, and said:

“In the early days of percutaneous transluminal coronary angioplasty (PTCA), each procedure took three to four hours to complete, and fully one in 20 patients suffered a heart attack in the catheterization laboratory. There was little an interventional cardiologist could do, other than rush the patient to surgery. Introduction of the steerable guidewire made PTCA easier to do and shortened procedure times. Development of the perfusion catheter meant that interventional cardiologists could re-establish blood flow to the heart and stabilize patients in case of a sudden arterial blockage. “(cited in David, 2006).

Risks of Participation in Randomized and Non-randomized Clinical Trials: Technology and Procedural Considerations

Assignment to a “control group” means implantation of a stent that is gold standard, rather than having the chance of benefiting from an innovative technology such as bioabsorabable stents (Guidant Corporation, 2006) or bioengineered stents (Chadwick, 2006).

During the clinical trials manufacturing defects in the device are identified after the device has been implanted in the participants but not in the control group. Wood (2006) reports that: Guidant Corporation has voluntarily stopped enrolling patients in several arms of the nonrandomized portion of its SPIRIT III clinical trial, because one out of every 100 Xience V everolimus-eluting stents may have been manufactured in substandard conditions. The Xience V everolimus-eluting stent received CE Mark approval in 1/2006. Earlier in March 2006, the company announced that it has completed enrollment of 1002 patients in the randomized US portion of the SPIRIT III trial, comparing the Xience V with the TAXUS paclitaxel-eluting stent. Company intents to restock investigators’ supplies and relaunch the trial.

Shortcomings of an entire generation of stent technology which is the Gold Standard in major hospitals in US – Drug Eluting Stents (DES)

Drug-eluting stents, introduced just a few years ago, markedly reduce the risk of restenosis. These stents have quickly become a mainstay of interventional therapy, but their use to treat large segments of the coronary circulation has created new challenges. (ABSORB, 2006, Menichelli, 2006, Pfisterer, 2006, Simonton, 2006, Turco, 2006)

Pfisterer, P.E. (2006) at American College of Cardiology 55th Annual ScientificSession, March 11 – 14, 2006, Atlanta, Georgia in his presentation on Basel Stent Cost-Effectiveness Trial-Late Thrombotic Events (BASKET LATE) Trialcompared Drug-eluting stents (DES) with Bare metal stents (BMS) and told the largest audience of interventional cardiologists in the US that

“The results of this small study and the conclusions reached by the authors are certainly a cause for concern. As has been demonstrated by previous studies, the rate of late stent thrombosis after DES implantation was not significantly higher than the rate associated with BMS, but, nevertheless, the consequences are dire. What I find especially troublesome is the fact that we cannot predict with certainty which patients are prone to develop late stent thrombosis and when stent thrombosis is likely to occur — the latter of which is extremely variable in relation to clopidogrel discontinuation. I am not completely convinced that we should advise all patients treated with a DES to continue dual antiplatelet therapy indefinitely, especially when considering high costs and the potential for bleeding complications. This issue generated plenty of debate at the ACC meeting and is far from being resolved” (Pfisterer, 2006).

Does his message have any impact on Cath Labs in US where thousand of drug-eluting stents are stocked and implanted everyday in thousands of cardiovascular patients, and patients with peripheral vascular diseases?

Risk Sources for Complication during Cardiac Catheterization: Patient participation in a randomized or non-randomized Clinical Trial for a new generation of stent devices

Clinical – iatrogenic, induced inadvertently by the medical treatment or procedures or activity of a physician
Procedural – no change in practice induced, though scientific evidence is available
Idiopathic,of the nature of an idiopathy, self originated, of unknown causation.

The first two risk types are addressed, below.

Clinical – iatrogenic, induced inadvertently by the medical treatment or procedures or activity of a physician

Access site complications

The most frequently observed complications are related to access site. Such complications, albeit rarely life-threatening, may require additional treatment, including further compression or thrombin injection (for pseudoaneurysms), blood transfusions or vascular surgery. Access site complications may also expose patients to further discomfort, a longer hospital stay and higher hospital costs. For local vascular complications, established predictors are older age, female gender, body surface area, peripheral vascular disease, some antithrombotic regimens and access site (Agostoni, et al. 2006).

Expertise level of the physician operator

A recent paper from a non-university hospital showed that expert operators (> 500 procedures performed) had an overall complication rate lower than cardiologists-in-training (despite the fact that it is not clear if they were cardiology fellows or interventional cardiologists-in-training), with a relative risk reduction of approximately 40%, Ammann, et al.(2003). This result is not confirmed by our report. Indeed, fellows, whose maximum caseload is around 300 procedures during the training period, can safely perform cardiac catheterizations, with a complication rate very similar to that of attending physicians. We focused, in particular, on local vascular complications, as arterial puncture is the first procedure step in the training of fellows and usually the only part of the examination they perform alone. An attending physician, who is directly responsible for the whole procedure, supervises the rest. In a recent registry on postcatheterization complications, it was stated: “the involvement of fellows-in-training may have contributed to some complications, especially local” according to Chandrasekar, B., et al.(2001). A study may well complement that report, suggesting the opposite conclusions (Agostoni, et al. 2006).

We report that for Procedural and during Procedure – no change in practice introduced though scientific evidence is available.

Extensive use of antithrombotic therapy

The majority of the patients reported in Agostoni, et al.(2006), underwent left heart catheterization because of suspected or known CAD. Thus, they were taking at least one antiplatelet drug despite the fact that it is common practice at our institution to administer a double antiplatelet regimen (aspirin associated with either ticlopidine or clopidogrel) at least 2 days prior to coronary angiography. And for patients with unstable symptoms, they routinely administer subcutaneous unfractionated or low-molecular-weight heparin, which has been shown to significantly increase the risk of local complications. Moreover, in these unstable patients, intravenous heparin was always administered during the procedure, irrespective of the concomitant administration of subcutaneous heparin. Nevertheless, the complication rate in catheterizations performed for reasons other than CAD remained particularly high (3.1%) (Agostoni, et al., 2006).

Selection of Access Site

In terms of arterial access site, the radial approach clearly reduced the rate of local complications, with an overall incidence of 0.8% compared to 3.4% after transfemoral catheterizations. A recently published meta-analysis comparing the radial versus the femoral approach for percutaneous coronary diagnostic and interventional procedures, including patients with similar overall characteristics, yielded results comparable to those of the present study. The radial artery approach was electively performed by one senior cardiologist and only occasionally by the others, while cardiology fellows did not perform any transradial procedures (Agostoni, et.al. 2006) [italics added].

If radial artery is implicated with less site access-related complications, why is radial artery used in 30% of the cases, and femoral artery in 70% of percutaneous coronary interventions (PCI)?

Additional Risk Factors for Complication during Cardiac Catheterization that are not routinely Checked or Used Peri-procedure.

Percutaneous left heart catheterization, including pressure measurements, left ventriculography, coronary angiography and percutaneous coronary interventions (PCI), is nowadays considered the gold standard for the diagnosis, evaluation and treatment of several cardiac diseases (coronary artery disease [CAD], valvular and congenital heart diseases, cardiomyopathies, status post-heart transplant) (Agostoni, et al. 2006).

Other variables may increase the probability of complication during Cardiac Catheterization.

These intermediate variables are not routinely checked or used. Thus, they compromise the patient’s chance of achieving the optimal medical results and the best of care. That is after playing the odds of obtaining an assignment in the clinical trial to the “Treatment Group” if a patient was not assigned to either the “Control Group” to be implanted a traditional device or to the “Placebo Group” calling for no device implantation on this round.

Among these variable one finds:

antithrombotic regimens other than GP IIb/IIIa inhibitors
body surface area calculation
identification and consideration of presence of peripheral vascular disease
absence of testing for systematic screening of serum CK-MB levels needed for detection of postprocedural myocardial infarction.
absence of cardiac enzymes measurement: before, after, follow up: 2 weeks, 1 month, 6 month, 12 month

Discussion

The first part of the paper deals with the physician’s medical dilemma of assigning patients to randomized clinical trials. The Moral Theory was contrasted with the Utilitarian one. My chosen side/stand on this matter is to identify my values with the Utilitarian group that will participate in randomized clinical trials if medical conditions so require.

In the second part of the paper, I dealt with a realm of risk factors the patient is exposed to after he/she has signed an informed consent and has no longer control. Noteworthy, the risk factors discussed in the paper are not included on any informed consent form. These risks call for modifications to current practices involved in stent implantation technology requiring an immediate consideration.

Two sources of risks were addressed: Clinical and Procedural. These sets of risks are identical for any patient in the Cath Lab, regardless of being assigned to the Treatment Group or to the Control Group. One may not assume that the implantation procedure for a traditional device vs. a new generation device, carries similar risk. Though the risk of complication during the procedure is very low, when it occurs to someone you care for or to yourself, it is very dire.

Major adverse cardiovascular and cerebrovascular events (MACCE: death, myocardial infarction, cerebrovascular event) were also assessed. The overall access site complication rate was 2.6%. On multivariate regression analysis, the only two predictors of local complications were female gender (odds ratio [OR] 3.2, 95% confidence interval [CI] 1.6–6.5) and femoral approach (OR 3.9, 95% CI 1.2–12.1). The rate of MACCE (major cardiovascular and cerebrovascular events was 1.2%, mainly after percutaneous coronary interventions, with only 1 death overall (0.07%)(Agostoni, et.al. 2006).

Like most medical ethics issues, there is no single right answer. I would recommend every Cath Lab to revisit every risk factor listed above, discuss them with the Ethics Committee in the Hospital and initiate new procedures to address the clinical and procedural risk factors identified in the context of First-In-Man Stent Implantation.

As other interventional cardiologists, we are looking forward to Generation Five of Stenting Technology that will include the following innovations:

(a) Stents eluding Nitric Oxide (Verma and Marsden, 2005);

(b) stents with coating of an antibody specific (anti-CD34) to the antigen cells that are in the blood, therefore capturing the patient’s circulating endothelial progenitor cells (cEPCs) in order to accelerate the natural healing process (Chadwick, 2006),(Aoki et al., 2005), (Ben-Shoshan & George, 2007), and

(c) EPC-covered intravascular stents deployed for prevention of stent thrombosis and restenosis as well as for rapid formation of normal tissue architecture (Shirota et al., 2003).

Patient safety will be improved if the risk factors identified will raise awareness and will be addressed — preferably, before the next procedure starts in Angiography/Angioplasty Suite #14, ten minutes from now!

According to Rogers & Edelman (2006), “the spectacular success of drug-eluting stents is still plagued by an aura of unease and an insistent drumbeat demanding evidence of success and safety…dramatic reduction in restenosis attended by enhanced rates of thrombosis.” The performance of the two FDA-approved drug-eluting stents (Taxus and Cypher) varies. Cypher is associated with lower restenosis risk. Both devices are pushed into very complex settings to include patients diagnosed with diabetes (different diabetic states may affect restenosis after stenting in different ways). Percutaneous interventions routinely performed in small-vessels, multilesions, diffuse disease, acute coronary syndrome settings and stent-inside-stent as followed up therapy to restenosis. Other failure modes are stent thrombosis, post-procedural myonecrosis, plaque rupture, enhanced disease at a distance and excitation of patients’ already heightened immune state. Other predictors of device failure include lesion type, patient demographics, prior history of coronary bypass surgery, calcification, degree of pre-stent and post-stent stenosis. The variation in performance is critical for patient care decisions and physician’s discrimination between alternative therapies. In most cases the device is selected by the interventional cardiologist with little or no input from the patient.

Research of Clinical/Ethical issues, to emerge in the context of development of clinical trials for First-In-Man Stents, as well as medical ethical issues, to arise during the implantation procedure of the device, and during the period of follow up of the installed base of the device in humans, requires formalization of the data collection and standardization of the statistical analysis procedures. The two leading conferences, where research findings are reported, in the US in 2006 [American College of Cardiology, Annual Scientific Session] and in Europe in 2006 [The European Paris Course on Revascularization (EuroPCR)] are currently presenting challenges for comparative analysis of safety and efficacy.

Development of a schematic rubric, a conceptual proposal for a future study on the “Ethical Medical Issues involved in Clinical Trials for Next Generation Stent Technology.” Implementation of such a study will be most beneficial to all parties involved: physicians, patients, FDA, device manufacturers and medical ethicists. It will involve the following comparative criteria:

Medical Ethical Issue
Clinical Trial Name
Stent Type
Number of Patients
Major adverse cardiac events
Treatment Efficacy
Follow up Studies
Clinical Trial Sites
Safety of Risk Factors
Study Discontinued

REFERENCES

ABSORB (2006). Everolimus Eluting Coronary Stent System First in Man Clinical Investigation. ClinicalTrials.gov Identifier: NCT00300131

Study start: March 2006; Expected completion: June 2011

Last follow-up: March 2011; Data entry closure: May 2011

http://www.clinicaltrials.gov/ct/gui/show/NCT00300131?order=1

Agostoni, P., Anselmi, M., Gasparini, G., Morando, G., Tosi, P., De Benedictis, M.L., Quintarelli, S., Molinari, G., Zardini, P., Turri, M. (2006). Safety of percutaneous left heart catheterization directly performed by cardiology fellows: A cohort analysis. The Journal of Invasive Cardiology, 18 (6), 248-252.

Ammann, P., Brunner-La Rocca H.P., et al. (2003). Procedural complications following diagnostic coronary angiography are related to the operator’s experience and the catheter size. Catheter Cardiovasc Interv , 59, 13–18.

Aoki, J., Serruys, P.W., van Beusekom, H., Ong, A.T., McFadden, E.P., Sianos, G., et al. (2005). Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol 45 (10), 1574–1579.

Ben-Shoshan, J. George, J. (2007). Endothelial progenitor cells as therapeutic vectors in cardiovascular disorders: From experimental models to human trials. Pharmacology & Therapeutics, 115, 25-36.

Chadwick , D.(2006) OrbusNeich’s Genous Bioengineered R-stent . Cath Lab Digest, 14 (1), 20-26

Chandrasekar, B., Doucet, S., Bilodeau, L., et al. (2001). Complications of cardiac catheterization in the current era: A single-center experience. Catheter Cardiovasc Interv , 52, 289–295.

David, K.B. (2006). Impressive Progress In Interventional Cardiology – From 1st Balloon Inflation To First Bioabsorbable Stent, Society for Cardiovascular Angiography and Interventions, http://www.scai.org, http://www.medicalnewstoday.com/medicalnews.php?newsid=43313

Freedman, B. (1992). A response to a purported ethical difficulty with randomized clinical trials involving cancer patients.Journal of Clinical Ethics, 3 (3), 231-234.

Guidant Corporation, (2006). Guidant Announces Enrollment of First Patient in Clinical Trial of the World’s First Fully Bioabsorbable Drug Eluting Coronary Stent, 3/9/2006, Source: Guidant Corporation, Indianapolis, IN, www.guidant.com

Hellman, S. and D.S. Hellman (1991). Of mice but not men: Problems of the randomized clinical trial. New England Journal of Medicine, 324 (22), 1589-1592.

Markman, M. (1992). Ethical difficulties with randomized clinical trials involving cancer patients: Examples from the field of gynecologic oncology. Journal of Clinical Ethics, 3 (3), 193-193.

Menichelli, M. (2006). Sirolimus Stent vs. Bare Stent in Acute Myocardial Infarction Trial. Presented at The European Paris Course on Revascularization (EuroPCR), May 16-19, 2006, Paris, France Paris, France. http://www.medscape.com/viewprogram/5505?rss

Pfisterer, P.E. (2006). Basel Stent Cost-effectiveness Trial-Late Thrombotic events (BASKET LATE) Trial. Presented at American College of Cardiology 55th Annual Scientific Session, March 11 – 14, 2006, Atlanta, Georgia. http://www.medscape.com/viewprogram/5185

Rogers, C. Edelman E.R. (2006). Pushing drug-eluting stents into uncharted territory, Simpler then you think – more complex than you imagine. Circulation, 113, 2262-2265.

Shirota, T., Yasui, H., Shimokawa, H. & Matsuda, T. (2003). Fabrication of endothelial progenitor cell (EPC)-seeded intravascular stent devices and in vitro endothelialization on hybrid vascular tissue. Biomaterials 24(13), 2295–2302.

Simonton, C. (2006). The STENT Registry: A real-world look at Sirolimus- and Pacitaxel-Eluting Stents. Cath Lab Digest, 14 (1), 1-10.

Turco, M. (2006). TAXUS ATLAS Trial – 9-Month results: Evaluation of TAXUS Liberte vs. TAXUS Express. Presented at The European Paris Course on Revascularization (EuroPCR), May 16-19, 2006, Paris, France Paris, France. http://www.medscape.com/viewprogram/5505?rss

Verma, S. and Marsden, P.A. (2005). Nitric Oxide-Eluting Polyurethanes – Vascular Grafts of the Future? New England Journal Medicine, 353 (7), 730-731.

Wood, S. (2006). Guidant suspends release of Xience V everolimus-eluting stent due to manufacturing standards http://www.theheart.org/article/679851.do

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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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Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Posted in 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, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmacotherapy of Cardiovascular Disease, tagged Cardiac Power Output (CPO), Heart Failure, Heart recovering and remodeling, Heart Transplant, Implantable Synchronized Cardiac Assist Device on July 23, 2012| 18 Comments »

Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED 3/24/2013

Abiomed Facing Reclassification of Heart Pump Medical Device

MARCH 18, 2013 / MEDICAL DEVICE BLOG

Reclassification can often be a stressful and expensive process for medical device manufacturers. The recent case of Abiomed, and reclassification of its Impella 2.5 cardiac assist pump, is an example of the consequences of regulatory shift after a product has already been launched on the market.

The Impella 2.5 example is one that has been borne out of the FDA’s initial willingness to make an exception for nonroller cardiovascular blood pumps. Although technically a Class III device, a regulatory exemption created an opportunity for this type of product to avoid the rigors of the pre-market approval process and instead be marketed via 510(k). The basis of the exemption had to do with Abiomed assuring the agency that its pump was similar to other nonroller-type pumps.

Unfortunately for the company, a recent FDA advisory panel (the Circulatory System Devices Panel) reviewed the exemption (in place since 2008) and recommended that the Impella 2.5 lose its Class III 510(k) status. This decision was made after a careful examination of the changing standards for medical device approval over the course of the last five years.

What does this mean for Abiomed? The reclassification will require that the company provide the FDA with specific information proving the safety and efficacy of the Impella 2.5 device. Abiomed is not optimistic about the potential to demonstrate the benefits of its product to the satisfaction of the agency, especially after a previous study did not offer a compelling argument in favor of the pump. The company has 18 months to complete the work required to gather the needed data to support a PMA. Sales of the pump can continue until the PMA is either accepted or rejected.

SOURCE:

http://www.aptivsolutions.com/blog/medical-device/2013/03/abiomed-facing-reclassification-of-heart-pump-medical-device/?goback=%2Egde_675087_member_223865458

Abiomed shares lower as FDA panel votes to retain Class III status for Impella

December 7, 2012 11:30 am by Paul Quintaro,

Abiomed, Inc. (Nasdaq: ABMD) last night announced that the U.S. FDA Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella®. The 515i Reclassification Panel’s confirmation of this category of device as Class III devices is consistent with both the current Class III classification for these device types and as recommended in the FDA’s briefing documents, released on December 3, 2012.

“We would like to thank the 515i Panel and FDA for their time and consideration, as well as Dr. Jeffrey Popma of Beth Israel Deaconess Medical Center and Dr. William O’Neill of Henry Ford Hospital, who highlighted the compelling body of clinical evidence supporting Impella, including the PROTECT II data set,” said Michael R. Minogue, President, Chairman and Chief Executive Officer, Abiomed. “We look forward to collaborating with the FDA on next steps and agree with the 515i Panel’s feedback that our existing data, combined with our U.S. registry, position us to work with the FDA to submit a PMA application. We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients.”

The FDA’s 515i program is designed to review all previously 510(k) cleared Class III devices and determine the appropriate controls to ensure safety and effectiveness for the intended use of these product categories. The classification of Impella as a Class III device requires Pre-Market Approval (PMA) controls (versus prior 510(k) Class III special controls) to ensure safety and effectiveness in the intended use. As per the 515i Reclassification Process and confirmed by the FDA Panel, products will remain on the market for a sufficient period to allow for manufacturers to submit and the FDA to review Pre-Market Approval applications.

As per the statues of the 515i program, there is no change to the current 510(k) clearance for Impella throughout the remaining steps of the reclassification process for Non-Roller Type Cardiopulmonary Bypass Pumps. Following yesterday’s Panel recommendation, the next steps in the 515i process include FDA issuance of a Proposed Final Order, followed by a period of public comment, FDA issuance of a Final Order, and then submission of Pre-Market Approval applications by manufacturers with devices in the category. Throughout this series of reclassification steps, Abiomed will continue to market the Impella family of heart pumps and looks forward to working with FDA to submit the necessary clinical data under the PMA application process.

SOURCE:
http://medcitynews.com/2012/12/abiomed-shares-lower-as-fda-panel-votes-to-retain-class-iii-status-for-impella/#ixzz2OUFvz168

Abiomed (NASDAQ: ABMD) is a pioneer and global leader in healthcare technology and innovation, with a mission of RECOVERING HEARTS AND SAVING LIVES. Abiomed CEO, Chairman, and President, Michael R. Minogue, has focused the company’s efforts on developing ground-breaking technologies designed to assist or replace the life-sustaining pumping function of the failing heart. The Company’s portfolio of products and services offer healthcare professionals an array of choices across a broad clinical spectrum. From the world’s first total replacement heart to the World’s Smallest Heart Pump, 1/100th the size of the heart with rapid and simple insertion, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.

http://www.abiomed.com/about/about-abiomed/

Quick Facts

Company founded in 1981

Corporate Headquarters: Danvers, Massachusetts

European Division: Aachen, Germany

Number of Employees: 400+

NASDAQ Symbol: ABMD

Only company with FDA approval for heart recovery

First and only World’s Smallest Heart Pump

First Total Artificial Heart

Abiomed Announces Record Fourth Quarter Revenue of $37.3 Million, Up 31% and Achieves Profitability for Full Fiscal Year

DANVERS, Mass., May 16, 2012 (GLOBE NEWSWIRE) — Abiomed, Inc. (Nasdaq:ABMD – News), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2012 revenue of $37.3 million, up 31% compared to revenue of $28.5 million in the same period of fiscal 2011, and GAAP net income of $2.6 million or $0.06 per diluted share compared to GAAP net loss of $1.8 million or a loss of $0.05 per basic and diluted share in the prior year. For the full fiscal year, total revenue was $126.4 million, up 25% compared to revenue of $101.2 million in the prior fiscal year and GAAP net income was $1.5 million or $0.04 per diluted share compared to GAAP net loss of $11.8 million or a loss of $0.32 per basic and diluted share in the prior year.

http://phx.corporate-ir.net/phoenix.zhtml?c=95629&p=irol-newsArticle&ID=1696354&highlight=

SYMPHONY – SYNCHRONIZED WORLD SMALLEST HEART PUMP ASSIST DEVICE [Symphony is not approved for use]

Promotes myocardial recovery/remodeling
Partial circulatory support device
Avoids issues with continuous full flow devices: GI bleeding, aortic valve dysfunction

Why Infraclavicular Fossa?

Most common site for device placement
Avoids thoracotomy/ sternotomy
Access to “central” circulation via subclavianartery
Previous or future sternotomiesnot an issue

DESIGN & OPERATION

An implantable, synchronized assist device
Placement in pacemaker pocket
Single graft to subclavianartery
Synchronized with subcutaneous EKG leads:Afterload reduction-Decreased LV work, Increases Cardiac Output, Increases coronary and systemic blood flow, Decreases filling pressure
Device output: 3.0 L/min at 100 bpm

PRODUCT POSITIONING

Meets goals for a less invasive, cost-effective partial assist device designed for recovery:

Improves hemodynamics, may improve QOL

Simple implantation, (No thoracotomy or sternotomy) -Pacemaker pocket

Simple device design, less costly/cost effective

Potential to optimize heart failure medications or future therapies (stem cell, pharma)

Designed to promote recovery with future explant (Promotes native heart recovery/remodeling with intent to explant)

Allows for short LOS and home discharge

 Limitations of current Heart Failure Therapy – Progression of disease impacts patient’s QOL

Prognosis poor with advanced heart failure

Limited heart transplant availability

Implantable LVADs require major operation, long hospitalizations, readmissions and are costly

No current implantable cardiac assist device has been designed for heart recovery/remodeling

SYMPHONY PROJECT STATUS

Early studies showed efficacy-NIH funding
Over 90 bovine implants and 25 cadavers in development process
Validated final device design
Successful GLP pre-clinical study completed
Ready for First in Man experience

SYMPHONY PRE-CLINICAL IMPLANTS

Bovine model with anastomosisto carotid artery

Mimics position in human implants
Initial studies showed efficacy in bovine heart failure model
Final GLP studies prior to first-in-man implants (n=6) 30 day implants, Warfarin(INR 2x baseline), anti-platelet therapy, full autopsies

Symphony: How it works

CURRENT PRODUCT PORTFOLIO

Impella: How it works

Impella 5.0 Axillary Insertion

Impella 5.0 Cut Down Insertion

Impella LD Insertion

Impella 2.5 Insertion

Automated Impella Controller

AB5000

REFERENCES on Importance of Cardiac Power Output (CPO)

Fincke R, Hochman JS, Lowe AM, et al. Cardiac Power Is The Strongest Hemodynamic Correlate of Mortality in Cardiogenic Shock: A Report From the SHOCK Trial Registry. J Am Coll Cardiol 2004;44(2):340-8

den Uil CA, Lagrand WK, van der Ent M, et al. Impaired Microcirculation Predicts Poor Outcome Of Patients With Acute Myocardial Infarction Complicated By Cardiogenic Shock. Eur Heart J 2010;31(24):3032-39

Mendoza DD, Cooper HA, Panza JA. Cardiac Power Output Predicts Mortality Across A Broad Spectrum Of Patients With Acute Cardiac Disease. Am Heart J 2007;153:366-70

Torgersen C, Schmittinger CA, Wagner S, et al. Hemodynamic Variables And Mortality In Cardiogenic Shock: A Retrospective Cohort Study. Crit Care 2009;13:R157

Torre-Amione G, Milo-Cotter O, Kaluski E, et al. Early Worsening Heart Failure In Patients Admitted For Acute Heart Failure: Time Course, Hemodynamic Predictors, And Outcome. J Card Fail 2009;15(8):639-44

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Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Posted in Bio Instrumentation in Experimental Life Sciences Research, 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, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmacotherapy of Cardiovascular Disease, tagged Cardiac Power Output (CPO), Heart Failure, Heart recovering and remodeling, Heart Transplant, Implantable Synchronized Cardiac Assist Device on July 11, 2012| 4 Comments »

Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Reporter: Aviva Lev-Ari, PhD, RN

http://www.abiomed.com/about/about-abiomed/

Quick Facts

Company founded in 1981

Corporate Headquarters: Danvers, Massachusetts

European Division: Aachen, Germany

Number of Employees: 400+

NASDAQ Symbol: ABMD

Only company with FDA approval for heart recovery

First and only World’s Smallest Heart Pump

First Total Artificial Heart

Abiomed Announces Record Fourth Quarter Revenue of $37.3 Million, Up 31% and Achieves Profitability for Full Fiscal Year

http://phx.corporate-ir.net/phoenix.zhtml?c=95629&p=irol-newsArticle&ID=1696354&highlight=

SYMPHONY – SYNCHRONIZED WORLD SMALLEST HEART PUMP ASSIST DEVICE [Symphony is not approved for use]

Promotes myocardial recovery/remodeling
Partial circulatory support device
Avoids issues with continuous full flow devices: GI bleeding, aortic valve dysfunction

Why Infraclavicular Fossa?

Most common site for device placement
Avoids thoracotomy/ sternotomy
Access to “central” circulation via subclavianartery
Previous or future sternotomiesnot an issue

DESIGN & OPERATION

An implantable, synchronized assist device
Placement in pacemaker pocket
Single graft to subclavianartery
Synchronized with subcutaneous EKG leads:Afterload reduction-Decreased LV work, Increases Cardiac Output, Increases coronary and systemic blood flow, Decreases filling pressure
Device output: 3.0 L/min at 100 bpm

PRODUCT POSITIONING

Meets goals for a less invasive, cost-effective partial assist device designed for recovery:

Improves hemodynamics, may improve QOL

Simple implantation, (No thoracotomy or sternotomy) -Pacemaker pocket

Simple device design, less costly/cost effective

Potential to optimize heart failure medications or future therapies (stem cell, pharma)

Designed to promote recovery with future explant (Promotes native heart recovery/remodeling with intent to explant)

Allows for short LOS and home discharge

 Limitations of current Heart Failure Therapy – Progression of disease impacts patient’s QOL

Prognosis poor with advanced heart failure

Limited heart transplant availability

Implantable LVADs require major operation, long hospitalizations, readmissions and are costly

No current implantable cardiac assist device has been designed for heart recovery/remodeling

SYMPHONY PROJECT STATUS

Early studies showed efficacy-NIH funding
Over 90 bovine implants and 25 cadavers in development process
Validated final device design
Successful GLP pre-clinical study completed
Ready for First in Man experience

SYMPHONY PRE-CLINICAL IMPLANTS

Bovine model with anastomosisto carotid artery

Mimics position in human implants
Initial studies showed efficacy in bovine heart failure model
Final GLP studies prior to first-in-man implants (n=6) 30 day implants, Warfarin(INR 2x baseline), anti-platelet therapy, full autopsies

Symphony: How it works

CURRENT PRODUCT PORTFOLIO

Impella: How it works

Impella 5.0 Axillary Insertion

Impella 5.0 Cut Down Insertion

Impella LD Insertion

Impella 2.5 Insertion

Automated Impella Controller

AB5000

REFERENCES on Importance of Cardiac Power Output (CPO)

Mendoza DD, Cooper HA, Panza JA. Cardiac Power Output Predicts Mortality Across A Broad Spectrum Of Patients With Acute Cardiac Disease. Am Heart J 2007;153:366-70

Torgersen C, Schmittinger CA, Wagner S, et al. Hemodynamic Variables And Mortality In Cardiogenic Shock: A Retrospective Cohort Study. Crit Care 2009;13:R157

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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

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.

Contact Us

Aviva Lev-Ari, PhD, RN

Leaders in Pharmaceutical Business Intelligence

Founder & Director of Pharmaceutical Business Intelligence Services

1-617-244-4024

avivalev-ari@alum.berkeley.edu

Follow me on

http://www.linkedin.com/in/avivalevari

https://twitter.com/#!/pharma_BI

http://www.linkedin.com/groups?gid=4346921&trk=hb_side_g

blog: http://pharmaceuticalintelligence.com

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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.

Contact Us

Aviva Lev-Ari, PhD, RN

Leaders in Pharmaceutical Business Intelligence

Founder & Director of Pharmaceutical Business Intelligence Services

1-617-244-4024

avivalev-ari@alum.berkeley.edu

Follow me on

http://www.linkedin.com/in/avivalevari

https://twitter.com/#!/pharma_BI

http://www.linkedin.com/groups?gid=4346921&trk=hb_side_g

blog: http://pharmaceuticalintelligence.com

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

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Voss Medical Products vossmedicalproducts.com

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Alliant Healthcare Products www.allianthealthcare.com

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

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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…

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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

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Maquet Cardiopulmonary Ag www.maquet-cp.com

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Bionic Medizintechnik GmbH www.bionic-jms.com

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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

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

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TriReme Medical, Inc. www.trirememedical.com

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Elixir Medical Corporation www.elixirmedical.com

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Abbott Hematology www.abbott.us

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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…

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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

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Datascope Corp. www.datascope.com

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Lemaitre Vascular, Inc. www.lemaitre.com

Maquet Inc. www.maquet.com

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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

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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…

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Scanlan International www.scanlaninternational.com

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Instrumed International, Inc. www.instrumedinc.biz

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Lemaitre Vascular, Inc. www.lemaitre.com

Uresil, LLC www.uresil.com

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Geister Medizintechnik GmbH www.geister.com

Olympus Imaging Corporation www.olympus.co.jp

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Dimeda Instrumente Gmbh www.dimeda.de

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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.

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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

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Guidewire Technologies, Inc. guidewiretech.com

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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

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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

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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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Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Posted in Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, HTN, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Pharmacotherapy of Cardiovascular Disease, Renal Denervation, tagged American Heart Association, Blood pressure, Boston Scientific, Cardiosonic, Cleveland Clinic, Covidien, Hypertension, Inc., Kona Medical, Medtronic, Mercator MedSystems, Millennium Research Group, ReCor Medical, Renal denervation medical devices, Renal denervation procedure, St. Jude, Vessix Vascular on June 13, 2012| 15 Comments »

Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Curator: Aviva Lev-Ari, PhD, RN

UPDATED 8/5/2013

VIEW VIDEO – Editorial the Heart.org

Renal denervation: Clinical lessons from around the world

Renal Denervation treatment represents a medical subfield, it has its roots in surgical sympathectomy techniques dating back to the 1930s. This radical approach to blood pressure control, which did not specifically target renal nerves, was ultimately abandoned due to associated perioperative complications. However, experience in renal transplantation, a procedure in which the renal nerves are selectively severed, suggests that the denervated kidney can maintain volume and electrolyte homeostasis.

http://ajpregu.physiology.org/content/298/2/R245.full

http://www.ncbi.nlm.nih.gov/pubmed/3326559?dopt=Abstract

Potential effects of renal denervation are on improved glucose control, sleep apnea, and treatment of heart failure syndromes and renal dysfunction – all consequences of sustained hypersympathetic activity.

Based on these observations, the specific targeting of renal nerves as a major operative in the pathophysiology of hypertension and other conditions associated with increased sympathetic activity (renal dysfunction and heart failure) appears to be an attractive therapeutic approach.

http://bmctoday.net/evtoday/2012/02/article.asp?f=renal-artery-denervation-a-brave-new-frontier

A new therapeutic paradigm of percutaneous renal artery denervation using the application of radiofrequency (RF) energy (Symplicity renal denervation system [Ardian, acquired by Medtronic, Inc., Minneapolis, MN]) has recently been demonstrated to be safe, effective, and durable in significantly reducing systolic blood pressure in patients with resistant hypertension.

This new technology represents the first time that physicians have been able to target renal nerves specifically via a catheter-based intervention. This endovascular approach opens the door to better understanding the relationship between sympathetic hyperactivity and hypertension.

Current therapeutic strategies center on lifestyle changes and pharmacologic interventions; however, the rates of blood pressure control and therapeutic efforts to reduce the rate of progression of hypertensive end-organ damage (resulting in myocardial infarction, stroke, and renal dysfunction) remain a neglected priority.

http://rd.springer.com/article/10.1007/s11906-010-0119-1

Renal denervation is used to treat uncontrolled hypertension, or high blood pressure, by the ablation of the nerves that line the renal arteries using a catheter. The Cleveland Clinic called renal denervation the No. 1 healthcare innovation of 2012. More than 12 million patients worldwide whose blood pressure remains uncontrolled despite taking three or more anti-hypertensive medications representing a global market opportunity for renal denervation that could ultimately grow to $30 billion. The Millennium Research Group estimates that the hypertension-treating devices could generate $4.4 billion per year, Bloomberg reported. That number could swell if the FDA indicates the systems for simple hypertension and not just the drug-resistant sort. As Bloomberg notes, a boom in hypertension devices would be a welcome development for the device industry, which has struggled over the past four years with recalls, litigation and regulatory woes, leading to a 7% decline in Standard & Poor’s Healthcare Equipment Index.

“At least 23 companies, mainly smaller, private companies are developing products,” Wang said, based on information she gathered at the American College of Cardiology Conference in Chicago in March.

http://medcitynews.com/2012/04/medtronic-aside-a-whole-host-of-firms-chasing-hypertension-market/

http://www.fiercemedicaldevices.com/story/bloomberg-hypertension-devices-could-pay-big-us/2012-05-25?utm_medium=nl&utm_source=internal

According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease, and a 7 percent decrease in overall mortality. Renal denervation has shown in clinical studies to be safe, durable and effective in reducing systolic blood pressure by as much as 20 percent.

Numerous analysts suggest that there are more than 12 million patients worldwide whose blood pressure remains uncontrolled, despite taking three or more anti-hypertensive medications. This represents a global market opportunity for renal denervation approaching $30 billion.

Procedure Benefits

Hypertension, though often asymptomatic, is the number one risk factor for premature death worldwide.¹ Renal Denervation (RDN) treatment aims to address this condition at its source to provide a substantial and durable reduction in blood pressure. After the procedure, people can often return to their normal activities quickly. The benefit is often achieved after several weeks to months.

Benefits and New Indications for Usage of Intravascular Stimulation/Ablation of Autonomics

1. Reduction in Heart Rate and Heart Rate Variability

Dr. Scherlag experiments noted changes in heart rate which have also been reported in SYMPLICITY HTN-1 and SYMPLICITY HTN-2 (8-9). The SYMPLICITY HTN-2 study demonstrated profound bradycardia in 13% of patients that was treated with atropine.

The intra-procedure effect on heart rate during renal artery denervation documented in the SYMPLICITY trials is also manifest long term by measuring heart rate variability (10). Indeed, cardiac effects would be expected with autonomic modulation. Besides the two example above showing that cardiac sympathetic denervation effects heart rate, there are many more that are just beginning to be reported in the literature.

These articles shows the effects of renal denervation on heart rate.

http://www.ncbi.nlm.nih.gov/pubmed/1735574
http://www.ncbi.nlm.nih.gov/pubmed/8777835

A Cleveland Clinic review article states: “Additionally, the resting heart rate was lower and heart rate recovery after exercise improved after the procedure, particularly in patients without diabetes.”
http://www.ccjm.org/content/79/7/501.full

2. Renal Sympathetic Denervation lowers Atrial Fibrillation

This article discusses the effect of renal sympathetic denervation on atrial fibrillation.

http://www.ncbi.nlm.nih.gov/pubmed/22585944

3. Regression of Left Ventricular Hypertrophy, Increase in Ejection Fraction (EF) and improved Diastolic Dysfunction

“Brandt reported regression of left ventricular hypertrophy and significantly improved cardiac functional parameters, including increase in ejection fraction and improved diastolic dysfunction, in a study of 46 patients who underwent renal denervation. This findings suggests a potential beneficial effect on cardiac remodeling.” (Brandt MC, Mahfoud F, Reda S, et al. Renal sympathetic denervation reduces left ventricular hypertrophy and improves cardiac function in patients with resistant hypertension. J Am Coll Cardiol 2012; 59:901–909)

4. Reduction in Ventricular Tachyarrhythmias (VT)

“Ukena reported reduction in ventricular tachyarrhythmias in two patients with congestive heart failure who had therapy-resistant electrical storm.” (Ukena C, Bauer A, Mahfoud F, et al. Renal sympathetic denervation for treatment of electrical storm: first-inman experience. Clin Res Cardiol 2012; 101:63–67)

5. Intravascular Stimulation of Autonomics Effects on Heart Failure

The most recent data from Europe shows the following effects on heart failure:

http://www.eurekalert.org/pub_releases/2012-08/esoc-rdg082712.php
http://www.theheart.org/article/1364267.do

Dr. Scherlag, writes, [N]early ten examples of the effects of “CARDIAC SYMPATHETIC DENERVATION” and what are the effects on the kidney?

No change in GFR. No change in creatinine.

http://pharmaceuticalintelligence.com/2012/09/02/imbalance-of-autonomic-tone-the-promise-of-intravascular-stimulation-of-autonomics/

Procedure Risks

Although major complications are uncommon, RDN treatment carries many of the same risks as an angioplasty procedure for the treatment of artery disease. The catheter insertion site could become infected, become bruised or bleed heavily. Other possible complications include heart attack, stroke, kidney damage or malfunction, heart rhythm disturbances, arterial damage, hypotension, sudden cardiac death, burns and pain. Imaging agents, pain medications and anti-spasm agents are commonly used during the procedure and carry known risks.

1. Mathers, C., et al. World Health Organization; 2009

http://www.ardian.com/ous/patients/benefits-risks.shtml

Medical Debate on the Procedure – The candidates are hypertensive patients receiving blood-pressure-lowering medication that are truly “resistant.”

The Symplicity system (Medtronic) is the far-and-away front runner, having demonstrated average office-based BP drops of 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline.

Upwards of 20 other companies, according to Dr Ron Waksman (Washington Hospital, DC), are busy developing competing systems, some of which were featured in a EuroPCR session devoted to emerging technologies in May 2012 in Paris.

Leading this pack is St Jude’s EnligHTN system, which received CE Mark on the opening day of the meeting. Dr Stephen Worthley (Royal Adelaide Hospital, Australia) presented 30-day results in 47 resistant-hypertension patients treated with the multielectrode, RF-ablation-based system. Mean office BP changes at one month in EnligHTN 1 were -28 systolic and -10 diastolic (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg.

https://www.massdevice.com/news/europcr-st-judes-enlightn-lowers-blood-pressure-faster-rival-systems

In terms of safety, no serious complications were seen in the renal artery or at the access site in the EnligHTN study; minor procedure-related events included four hematomas, three vasovagal responses to sheath removal, and two postprocedure transient bradycardias.

Other devices featured in the session included a second RF-energy system and two ultrasound systems, see below technology description by supplier.

The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is. Principal investigator Prof. Stephen Worthley said in prepared remarks. “From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients.” St. Jude’s study included 47 patients with high blood pressure that wasn’t managed with drug therapy. Participants had an average of 176/96 mmHg baseline blood pressure, despite taking multiple medications, before the denervation procedure and an average of 148/87 mmHg after. More than 40% had systolic rates below 140 mmHg.

http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1695802

Interventionalists who spoke with heartwire were unvaryingly excited about the potential of renal denervation, with some caveats.

“You need enthusiasm to develop new things, and in hypertension we haven’t seen an innovation in decades,” Dr Thomas Lüscher (University Hospital Zürich, Switzerland) told heartwire. “So just the possibility that you would be able to have a persistent treatment effect by a procedure that helps severe hypertension patients and maybe in the future even the option to cure hypertension is very exciting indeed. But I agree it’s a dream at this point. I think we need the SYMPLICITY HTN 3 trial, which hopefully will confirm what the other studies have shown.”

Now enrolling at as many as 90 US centers, SYMPLICITY HTN 3, Lüscher pointed out, has design characteristics addressing two concerns with the earlier trials, namely a sham procedure for the control group and ambulatory blood-pressure monitoring in all patients.

During the same emerging-technologies session, Lüscher explored the albeit-scant data supporting a role for renal denervation in other conditions: everything from metabolic syndrome and obstructive sleep apnea to heart failure, atrial fibrillation, and polycystic-ovary syndrome.

But his counterpoint, Dr Jean Renkin (UCL St Luc University Hospital, Brussels, Belgium), was skeptical, pointing to the myriad unanswered questions with the technology.

“Currently, reasonably solid data are available only for patients with hypertension resistant to pharmacotherapy, which cannot necessarily be extrapolated to other forms of hypertension or conditions referred to [by Dr Lüscher]. However, at this point in time, no clouds have appeared in the sky, so let us dream on.”

Dr Renkin had one staggering number for the audience to consider: of 5000 patients who have undergone renal denervation, only 250 were actually treated as part of clinical studies. While no device has US approval, five denervation systems already hold CE Mark in Europe and are being used with increasing frequency.

Treating the Truly Medication Treatment “Resistant”

For a comprehensive presentation of Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes, refer to

http://pharmaceuticalintelligence.com/2012/05/29/445/

Another talking point is the proportion of patients who are truly “resistant.” The number agreed on by Lüscher, Waksman, and session comoderator Dr Robert Whitbourn (St Vincent’s Hospital, Fitzroy, Australia) was that just 3% of all hypertensive patients receiving blood-pressure-lowering medication are truly “resistant.” Numbers as high as 30% have been suggested in other reports, he noted.

“Interestingly, when we’ve been involved in various trials, every cardiologist says they have hundreds of these patients, but when we actually go to get them, no one actually has any,” Whitbourn quipped. “I think it should be a sobering thought—the numbers are actually quite small.”

Dr William Wijns (Cardiovascular Center Aalst, Belgium), also speaking with heartwire, agreed that the subset was “small” but argued it was “still big numbers, millions of people,” and “a massive unmet need.”

Waksman, insisting he was “excited” by what he called “robust reductions in blood pressure,” nevertheless urged eager interventionalists to work with hypertension experts and resist the urge “to jump on patients before we truly verify that they are resistant to medical treatment.”

In the vast majority of people even for whom renal denervation is appropriate, it “won’t be a cure,” Waksman said. “Most of these patients will have to continue on medical treatment—this is not replacing medical treatment, it is just getting [patients] more in control.”

http://www.theheart.org/article/1402321/print.do

The Global Supplier Ecosystem for Renal Denervation Systems

US Campbell, CA Kona Medical is attempting to address these limitations. The system delivers energy from outside the patient to the renal nerves. Ultimately, the procedure will be a “no puncture,” noninvasive technique, compatible with technologies that will allow for temperature and lesion mapping. A noninvasive procedure will allow titration of the therapy— that is, the application of patient-specific dose fractions while monitoring therapeutic effect in between fractions. The basis of the technology is focused ultrasound, not high intensity (HIFU) as one might see and expect in the treatment of tumors, but low-intensity focused ultrasound (LIFU). The biologic underpinnings of this treatment are described in past literature for treating nerves using ultrasound. Kona noninvasive system. The system is depicted in a custom chair; another version of the system is compatible with a standard fluoroscopy or MRI table. Both ultrasound (through elastography and the evolution of temperature mapping and MRI) allow further imaging and analysis of the treatment area. The dose distribution surrounding the artery is that of an annular ring around the wall of the artery. Kona has shown in animal studies that a heat/vibratory cloud at one plane along the artery is highly effective at long-term inhibition of renal nerves with no visible effect on any portion of the artery at any time point.

US, Ronkonkoma, NY & Germany – Paradise by ReCor Medical 6-F compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a more efficient renal denervation procedure First-in-human (15 patients at 3 months) BP drop, mm Hg -32/-16 at 3 mo. The ultrasound transducer lies within a low-pressure balloon that allows for self-centering of the transducer and gentle contact with the artery wall for uniform circumferential denervation. This means that nerves below the surface of the artery wall are damaged in 360° with a single emission. The balloon also enables cooled fluid to circulate during the energy delivery process, thereby cooling the endothelial wall and protecting it from any excessive heating that could be caused by other energy sources or designs. Preliminary F-I-M clinical data for PARADISE were reported previously at the “TRenD 2012” transcatheter renal denervation scientific meeting by cardiologist Thomas A. Mabin, M.D., Vergelegen Medi-Clinic, South Africa. The updated PARADISE data show that systolic blood pressure was reduced by a statistically significant average of 36 mm Hg in 8 patients at 90-days follow-up. The scientific literature demonstrates that only a 5 mm Hg reduction in BP results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality.

US, San Leandro, CA The Mercator Bullfrog by Mercator MedSystems, Inc. is a catheter-guided system designed to inject therapeutic agents directly, nonsystemically, and safely through blood vessel walls into adventitial tissues and has received US Food and Drug Administration 510(k) clearance. The Bullfrog catheter is tipped with a balloon-sheathed microneedle and is guided and inflated in a manner similar to an angioplasty catheter but with far lower expansion pressures (2 atm vs 6–20 atm) in vessels of 3 to 6 mm in diameter. It is compatible with 0.014-inch guidewires and 6-F introducer sheaths. When the desired injection site is reached, the balloon is inflated with saline and radiopaque contrast, securing the system for injection and sliding the microneedle through the vessel wall. Nonclinical studies have shown that the Bullfrog catheter is able to deliver up to 5 mL per injection into the renal artery adventitia with no apparent safety concerns. Guanethidine Ismelin) is delivered to the renal artery adventitia to accomplish sympathetic denervation. Given locally, guanethidine is known to induce an autonomic denervation directly and through an immune-mediated pathway. Mercator’s preclinical experiments have shown that guanethidine, injected at appropriate concentrations into the adventitial space around renal arteries, selectively ablates the nerves in the adventitia around the renal artery after a single, 20-minute procedure

J Neurosci. 1983;3:714-724

US – Laguna Hills, CA – V² Radiofrequency Baloon by Vessix Vascular, Inc. Bipolar RF balloon catheter REDUCE-HTN pilot (10 patients)

BP drop, mm Hg -30/-11 at 1 mo V ² catheter, a patented noncompliant balloon catheter with RF electrodes and thermistors mounted on the exterior of the balloon, and the proprietary V ² bipolar RF generator. Once inserted into the renal artery, a 30-second inflation/treatment per renal artery delivers simultaneous RF therapy with independent temperature control to all electrode pairs. V ² catheter is available in balloon diameters ranging from 4 to 7 mm, with a balloon length of 25 mm. Larger-diameter balloons have eight electrode pairs, and smaller-diameter balloons have four to six electrode pairs made of solid gold, which are biocompatible and facilitate good electrode contact with the renal arterial wall. In addition, the electrodes are radiopaque, allowing the V ² catheter to be easily visualized under fluoroscopy. Beginning in the first quarter of 2012, the V 2 renal denervation system will be utilized in the company’s first international, multicenter clinical study: REDUCEHTN.

Israel, Tel Aviv – Tivus by Cardiosonic A6-F transducer-tipped catheter, ultrasound energy (Animal data only) The solution for renal denervation is a high-intensity, nonfocused ultrasonic (US) catheter system named TIVUS (Therapeutic IntraVascular UltraSound) (Figure 3). By applying ultrasonic energy, the TIVUS technology enables remote, localized, controlled, and repeatable thermal modulation of the renal vessel wall tissue, resulting in safe renal nerve ablation. The remote thermal effect is located in the adventitia and perivascular region, with no thermal damage to the endothelium and media, therefore, preventing the development of vessel injury processes. Swine kidney tissue NE concentrations at 30- and 90-day follow-up have demonstrated successful renal denervation as witnessed by a 50% or more decline in tissue NE. Localized tissue thermal modulation/ablation, without damage to the blood vessel wall.

US, MN – SYMPLICITY HTN 2 by Medtronic average office-based BP drops of BP drop, mm Hg 32/12 mm Hg at six months in the SYMPLICITY HTN 2 trial, as reported by heartwire, with 84% of patients having had a >10-mm-Hg drop in systolic blood pressure from baseline. 14 points in 30 days and 27 points after 1 year. Available in Europe. Medtronic is the furthest ahead in its development process, predicting it will get Symplicity on the American market by 2015. catheter in the renal artery near each kidney to deliver radiofrequency energy to ablate the nerves. A single electrode in contrast to St. Jude’s mutli-electrode approach, is already on the road to FDA review with clinical trials approved last summer in the U.S. Symplicity system has been safely used in nearly 5,000 patients since commercialization

US, MN – EnligHTN 1 by St Jude radiofrequency (RF) energy to create lesions (tiny scars) along the renal sympathetic nerves Mean office BP changes at one month in BP drop, mm Hg 28 systolic and -10 diastolic after 1 month (p<0.0001 from baseline), with 78% of patients having systolic BP drops of >10 mm Hg. St. Jude Medical’s (St. Paul, MN) announcement in late 2011 of the first patient to be enrolled in their first-in-man ARSENAL trial ¹⁵ at the University of Adelaide

Ireland, Dublin – OneShot™ by Covidien acquisition of Maya Medical, Saratoga, CA New Irrigated RF Balloon Catheter secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013. Presumably, a filing with the FDA would follow that. the OneShot renal denervation system, was born out of the company’s extensive expertise in radiofrequency (RF) ablation and percutaneous coronary interventions (PCI), drawing upon the benefits and best practice standards of each distinct yet complementary clinical discipline. The result is a unique product platform that could further accelerate the paradigm shift in the management of resistant hypertension. consistent with Maya’s balloon-based approach is the ability to deliver predictable apposition of the RF electrode to the vessel wall for more controlled targeted delivery of the RF energy. By offering a more reliable single-treatment approach coupled with enhanced ease of use and reduced procedure times, Maya Medical believes its OneShot renal denervation system has the potential to significantly expand clinical adoption

http://bmctoday.net/evtoday/2012/02/article.asp?f=renal-artery-denervation-a-brave-new-frontier

US, Natick, MA Boston Scientific lags behind in the race to cash in on hypertension-treating devices, incoming CEO Michael Mahoney said at a Monday conference that it has a plan for its RDN renal denervation system. As MassDevice reports, Mahoney said Boston Sci expects to secure first human use for the device in the third quarter of this year, followed by a CE mark for the drug-resistant hypertension treatment in 2013.

St Jude’s EnligHTN system

Said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division “This launch is important because it represents a significant growth opportunity and exemplifies our commitment to advancing the practice of medicine. We’ve applied the decades of insight we’ve gained from developing successful ablation technologies that treat cardiac arrhythmias to establish an innovative solution for hypertension.” With the unique basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals. Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies. Additionally, the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure. The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to deliver effective therapy.

http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1695802

http://medgadget.com/2012/05/st-jude-medical-launches-enlightn-renal-denervation-system.html

St Jude’s EnligHTN system – view video

http://www.sjmprofessional.com/Products/Intl/Renal-Ablation-Therapy/enlightn-renal-denervation-system.aspx

Covidien

Unveiled a Novel Renal Denervation System OneShot™ at EuroPCR congress in Paris on 5/16/2012. “Live” Cases with New Irrigated RF Balloon Catheter for Treatment of Medication-resistant Hypertension and poor outcomes of pharmacological agents. The OneShot system is an irrigated, radiofrequency (RF) based balloon catheter used to ablate the renal sympathetic nerves located in the outer wall of the renal arteries. The OneShot technology received CE mark clearance in February 2012.

The OneShot system was featured in “live” cases at the Covidien-sponsored “Tools & Techniques (TNT) Interventions” presentation and panel session for hypertension and renal denervation at the EuroPCR congress. Professor Dirk Scheinert performed two cases at Park Hospital in Leipzig, Germany, that were transmitted live at the Palais des Congrès de Paris. In addition, John Ormiston, MD, Medical Director for Mercy Angiography and President of the Asia-Pacific Society of Interventional Cardiology in New Zealand, presented first-in-human results of cases performed with the OneShot system in New Zealand. The OneShot system and Covidien’s other endovascular solutions was on display at the EuroPCR meeting.

Additional faculty in the TNT session is a distinguished group of speakers including:

Professor Karl-Heinz Kuck, MD, F.A.C.C. – Director, Cardiology Department Allgemeines Krankenhaus St. Georg – Hamburg, Germany

Dr. Stephen R. Ramee, FACC, FSCAI Ochsner Medical Center – New Orleans, Louisiana

Dr. John Ormiston, MBChB, FRACP – Medical Director Mercy Hospital Angiography Unit – Auckland, New Zealand

Professor Marc Sapoval, MD, PhD – Department Head Cardiovascular/Interventional Radiology – Hospital Pompidou University – Paris, France

Dr. Renu Virmani – Medical Director CVPath Institute – Gaithersburg, Maryland

Covidien discloses that it purchased Maya Medical for $60 million in cash on April 20. If Maya Medical meets certain regulatory and sales milestones, it will receive up to an additional $170 million. Covidien notes that Maya Medical’s OneShot system received the CE Mark in February.

MedCity News was the first to report Covidien’s interest in Maya Medical on 5/8/2012.

In a note to investors Monday, analyst Bob Hopkins of Bank of America said that renal denervation “has the potential to be one of the largest new markets in medtech over the next 2-4 years and for [Covidien] this looks like another small deal with big potential.”

http://medcitynews.com/2012/05/covidien-discloses-60m-purchase-of-hypertension-treatment-firm/?edition=medical-devices

Clinical Trial for RAPID is ongoing

Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)

This study is currently recruiting participants.

Verified June 2012 by Maya Medical

First Received on January 25, 2012. Last Updated on June 4, 2012 History of Changes

Sponsor:	Covidien (Maya Medical)
Collaborator:	Meditrial Europe LTD
Information provided by (Responsible Party):	Maya Medical
ClinicalTrials.gov Identifier:	NCT01520506

Purpose

Maya Medical OneShot™ Ablation System use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Condition	Intervention	Phase
Hypertension, Resistant to Conventional Therapy	Device: Maya Medical OneShot	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy StudyIntervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title:	Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the Maya Medical OneShot™ Ablation System

http://www.clinicaltrials.gov/ct2/results?term=Renal+Denervation&pg=2&show_flds=Y

Covidien into direct competition with Medtronic, whose Symplicity renal denervation system is approved in Europe. Currently, the system is being tested in the U.S. St. Jude Medical, Medtronic’s in-state rival, is also developing a therapy and that is expected to have a limited European market launch before the end of the year. But it is not only the larger players that Covidien will have to play against in Europe. A whole host of companies is developing products there, including ReCor Medical.

http://www.canada.com/entertainment/ReCor+Medical+discloses+data+from+clinical+study+PARADISE+ultrasound/6430884/story.html

Medtronic

Medical device giant Medtronic (NYSE: MDT), November 23, 2010 said it has agreed to pay $800 million upfront, plus commercial milestone payments through 2015, to acquire Mountain View, CA-based Ardian. Medtronic had previously built up an 11 percent ownership stake in Ardian, when it invested with its venture backers, which include Morgenthaler Ventures, Advanced Technology Ventures, Split Rock Partners, and Emergent Medical Partners. Ardian’s windfall comes about one week after it presented some eye-opening clinical trial results in The Lancet, and at the American Heart Association’s scientific meeting.

http://www.xconomy.com/san-francisco/2010/11/23/medtronic-buys-ardian-for-800m-upfront-grabs-novel-treatment-for-high-blood-pressure/

Clinical Trial for SYMPLICITY is ongoing.

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

This study is currently recruiting participants.

Verified June 2012 by Medtronic Vascular

First Received on August 15, 2011. Last Updated on June 11, 2012 History of Changes

Sponsor:	Medtronic Vascular
Information provided by (Responsible Party):	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT01418261

Purpose

The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter – a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.

Condition	Intervention	Phase
Uncontrolled Hypertension	Device: Renal denervation (Symplicity Catheter System)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Single Blind (Subject)Primary Purpose: Treatment

http://clinicaltrials.gov/ct2/show/NCT01418261

The Symplicity™ Renal Denervation System has two main components:

The elements are designed to work together as an integrated system to ensure consistent performance:

Symplicity™ Catheter – Low profile, endovascular energy delivery catheter

Symplicity™ Generator – Automated, portable RF generator

The Symplicity Renal Denervation System uses controlled, low-power radiofrequency (RF) energy to deactivate the renal nerves, thereby selectively reducing both the pathologic central sympathetic drive to the kidney and the renal contribution to central sympathetic hyperactivity. The outcome, we hope, will be a significant and sustained reduction in both blood pressure and the level of systemically damaging neurohormones. Since the endovascular procedure does not involve an implant, patients recover quickly and can soon return to their daily living. The device may usher in a new era in the treatment of hypertension, hopefully allowing a one-time procedure to offer patients a long-lasting benefit.

Medtronic Procedure – view video

http://www.ardian.com/ous/medical-professionals/procedure.shtml

Conclusions

The entire industry subsegment is awaiting the results of SYMPLICITY HTN-3. Forecasts of market share by supplier will be predicated on this Clinical Trial completion.

Shutting down overactive nerves around the kidneys as a strategy for fighting resistant hypertension is “one of the most exciting growth markets in medical devices,” Sean Salmon, vice president and general manager of Medtronic’s coronary and peripheral business, said in a statement.

I had a piece in these pages last week about what kind of difference the Ardian treatment was making. The most recent Ardian study showed the new treatment, in combination with standard drugs, was able to bring average blood pressure scores down from 178 over 97 to 146 over 85 after six months of follow-up, while those who just got standard treatments were essentially unchanged. The results were “a big achievement,” according to Murray Esler, the study’s principal investigator.

http://www.xconomy.com/san-francisco/2010/11/23/medtronic-buys-ardian-for-800m-upfront-grabs-novel-treatment-for-high-blood-pressure/

Resources

REFERENCES for Dr. Scherlag’s 1999 Patent and pioneering work on Intravascular Stimulation/Ablation of Autonomics

1. Schauerte P, Scherlag BJ, Scherlag MA, Goli S, Jackman WM, Lazzara R. Transvenous parasympathetic cardiac nerve stimulation: an approach for stable sinus rate control. J Electrophysiol. 1999 Nov;10(11):1517-24.

2. Schauerte P, Scherlag BJ, Scherlag MA, Goli S, Jackman WM, Lazzara R. Ventricular rate control during atrial fibrillation by cardiac parasympathetic nerve stimulation: a transvenous approach. J Am Coll Cardiol. 1999 Dec;34(7):2043-50.

3. Schauerte P, Scherlag BJ, Pitha J, Scherlag MA, Reynolds D, Lazzara R, Jackman WM. Catheter ablation of cardiac autonomic nerves for prevention of vagal atrial fibrillation. Circulation. 2000 Nov 28;102(22):2774-80.

4. Scherlag MA, Scherlag BJ, Yamanashi W, Schauerte P, Goli S, Jackman WM, Reynolds D, Lazzara R. Endovascular neural stimulation via a novel basket electrode catheter: comparison of electrode configurations. J Interv Card Electrophysiol. 2000 Apr;4(1):219-24.

5. Scherlag BJ, Yamanashi WS, Schauerte P, Scherlag M, Sun YX, Hou Y, Jackman WM, Lazzara R. Endovascular stimulation within the left pulmonary artery to induce slowing of heart rate and paroxysmal atrial fibrillation. Cardiovasc Res. 2002 May; 54(2):470-5.

6. Hasdemir C, Scherlag BJ, Yamanashi WS, Lazzara R, Jackman WM. Endovascular stimulation of autonomic neural elements in the superior vena cava using a flexible loop catheter. Jpn Heart J. 2003 May;44(3):417-27.

7. Webster W Jr, Scherlag BJ, Scherlag MA, Schauerte P. Method and apparatus for transvascular treatment of tachycardia and fibrillation. US Patent 6,292,695. Filed June 17, 1999.

8. Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281.

9. Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.

10. Frank Himmel MD, Joachim Weil MD, Michael Reppel MD, Kai Mortensen MD, Klaas Franzen, Leidinger Ansgar MD, Heribert Schunkert MD, Frank Bode MD. Improved Heart Rate Dynamics in Patients Undergoing Percutaneous Renal Denervation. Letter to the Editor. JCH. 31 MAY 2012.1751-7176.

Sympathetic Hyperactivity & Hypertension

For more information on hypertension, please visit the medical professional hypertension portal at TheHeart.org .

Siddiqi L, Joles JA, Grassi G, Blankestijn PJ. Is kidney ischemia the central mechanism in parallel activation of the renin and sympathetic system? J Hypertens. 2009 Jul;27(7):1341-9.

Augustyniak RA, Tuncel M, Zhang W, Toto RD, Victor RG. Sympathetic overactivity as a cause of hypertension in chronic renal failure. J Hypertens. 2002;20(1):3-9.

DiBona GF. Sympathetic nervous system and the kidney in hypertension. Curr Opin Nephrol Hypertens. 2002;11(2):197-200.

Mancia G, Grassi G, Giannattasio C, Seravalle G. Sympathetic activation in the pathogenesis of hypertension and progression of organ damage. Hypertension. 1999;34(4 Pt 2):724-728.

References in Scientific Journals about Renal Denervation Treatment

Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-1909.

Symplicity HTN-1 Investigators. Catheter-Based Renal Sympathetic Denervation for Resistant Hypertension – Durability of Blood Pressure Reduction Out to 24 Months. Hypertension. Volume 57, Number 5, May 2011.

Rippy, M. et al. Catheter-Based Renal Sympathetic Denervation: Chronic Preclinical Evidence for Renal Artery Safety. Clin Res Cardiol. 2011 Dec; 100(12): Pages 1095-1101.

Mahfoud, F. et al. Effect of Renal Sympathetic Denervation on Glucose Metabolism in Patients With Resistant Hypertension. Circulation. Volume 123, No. 18, May 10, 2011. Pages 1940-1946.

Witkowski A., et al. Effects of Renal Sympathetic Denervation on Blood Pressure, Sleep Apnea Course, and Glycemic Control in Patients with Resistant Hypertension and Sleep Apnea. Hypertension. Volume 58, Number 4, October 2011. Pages 559-565.

Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009;373(9671):1275-1281.

Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD. Renal Sympathetic-Nerve Ablation for Uncontrolled Hypertension. N Engl J Med. 2009;361(9):932-934.

Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal Denervation as a Therapeutic Approach for Hypertension. Novel Implications for an Old Concept. Hypertension. 2009;54(6):1195-1201.

Esler M. The 2009 Carl Ludwig Lecture: pathophysiology of the human sympathetic nervous system in cardiovascular diseases: the transition from mechanisms to medical management. J Appl Physiol. 2010;108(2):227-237.

Dibona GF, Esler MD. Translational Medicine: the antihypertensive effect of renal denervation. Am J Physiol Regul Integr Comp Physiol. 2010;298(2):R245-253.

Katholi RE, Rocha-Singh KJ. The role of renal sympathetic nerves in hypertension: has percutaneous renal denervation refocused attention on their clinical significance? Prog Cardiovasc Dis. 2009;52(3):243-248.

Doumas M, Faselis C, Papademetriou V. Renal Sympathetic Denervation and Systemic Hypertension. Am J Cardiol. 2010;105(4):570-576.

Schlaich MP, Krum H, Sobotka PA. Renal sympathetic nerve ablation: the new frontier in the treatment of hypertension. Curr Hypertens Rep. 2010;12(1):39-46.

Katholi RE, Rocha-Singh KJ, Goswami NJ, Sobotka PA. Renal nerves in the maintenance of hypertension: A potential therapeutic target. Curr Hypertens Rep. 2010;12:196-204.

Esler MD, Lambert EA, Schlaich M, Navar LG. The Dominant Contributor to Systemic Hypertension: Chronic Activation of the Sympathetic Nervous System vs Activation of the Intrarenal Renin-Angiotensin System. J Appl Physiol. 2010.

Fisher JP, Fadel PJ. Therapeutic strategies for targeting excessive central sympathetic activation in human hypertension. Exp Physiol. 2010;95(5):572-580.

Malpas SC. Sympathetic nervous system overactivity and its role in the development of cardiovascular disease. Physiol Rev. 2010;90:513-557.

Lambert GW, Straznicky NE, Lambert EA, Dixon JB, Schlaich MP. Sympathetic nervous activation in obesity and the metabolic syndrome–causes, consequences and therapeutic implications. Pharmacol Ther. 2010;126:159-172.

Masuo K, Lambert GW, Esler MD, Rakugi H, Ogihara T, Schlaich MP. The role of sympathetic nervous activity in renal injury and end-stage renal disease. Hypertens Res. 2010;33:521-528.

Schlaich MP, Socratous F, Hennebry S, Eikelis N, Lambert EA, Straznicky N, Esler MD, Lambert GW. Sympathetic activation in chronic renal failure. J Am Soc Nephrol. 2009;20(5):933-939.

Bock JS, Gottlieb SS. Cardiorenal syndrome: New perspectives. Circulation. 2010;121:2592-2600.

Goldsmith SR, Sobotka PA, Bart BA. The sympathorenal axis in hypertension and heart failure. Journal of Cardiac Failure. 2010;16(5):369-373.

Grassi G. Assessment of sympathetic cardiovascular drive in human hypertension: achievements and perspectives. Hypertension. 2009;54(4):690-697.

Ritz E. New approaches to pathogenesis and management of hypertension. Clin J Am Soc Nephrol. 2009;4(12):1886-1891.

Ritz E, Rump LC. Control of sympathetic activity–new insights; new therapeutic targets? Nephrol Dial Transplant. 2010;25(4):1048-1050.

Joyner MJ, Charkoudian N, Wallin BG. Sympathetic nervous system and blood pressure in humans: Individualized patterns of regulation and their implications. Hypertension. 2010;56:10-16.

Mann JF. Whats new in hypertension 2009? Nephrol Dial Transplant. 2010;25(1):37-41.

Bravo EL, Rafey MA, Nally JV, Jr. Renal denervation for resistant hypertension. Am J Kidney Dis. 2009;54(5):795-797.

King A. Hypertension: RF ablation of renal nerves. Nature Reviews Nephrology. 2009;5:364.

Doumas M, Douma S. Interventional management of resistant hypertension. Lancet. 2009;373(9671):1228-1230.

Paulis L. Novel therapeutic targets for hypertension. Nat Rev Cardiol. 2010.

OBrien E. Renal sympathetic denervation for resistant hypertension. Lancet. 2009;373(9681):2109; author reply 2109-2110.

Titze S, Uder M, Schmieder R. Renal nerve ablation: innovative therapy for treatment of resistant hypertension. MMW Fortschr Med. 2009;151(42):52-53.

Katona PG. Biomedical engineering in heart-brain medicine: A review. Cleve Clin J Med. 2010;77 Suppl 3:S46-50.

Abstracts about Renal Denervation Treatment

Schlaich M, Krum H, Walton T, Whitbourn R, Sobotka P, Esler M. Two-year durability of blood pressure reduction with catheter-based renal sympathetic denervation. Journal of Hypertension. 2010;28:e446.

Esler M, Schlaich M, Sobotka P, Whitbourn R, Sadowski J, Bartus K, et al. Catheter-Based Renal Denervation Reduces Total Body and Renal Noradrenaline Spillover and Blood Pressure in Resistant Hypertension. Journal of Hypertension. 2009;27(suppl 4):s167.

Schlaich MP, Krum H, Whitbourn R, Walton T, Lambert GW, Sobotka PA, et al. Effects of Renal Sympathetic Denervation on Noradrenaline Spillover and Systemic Blood Pressure in Patients with Resistant Hypertension. Journal of Hypertension. 2009;27(suppl 4):s154.

Schlaich M, Krum H, Walton T, Lambert E, Lambert G, Sobotka P, et al. A Novel Catheter Based Approach to Denervate the Human Kidney Reduces Blood Pressure and Muscle Sympathetic Nerve Activity in a Patient with End Stage Renal Disease and Hypertension. Journal of Hypertension. 2009;27(suppl 4):s437.

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Archive for the ‘Massachusetts Niche Suppliers and National Leaders’ Category

FDA Approval for Under-Skin Defibrillator goes to Boston Scientific Corporation

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Absorb™ Bioresorbable Vascular Scaffold: An International Launch by Abbott Laboratories

On this Scientific Web Site the, Cardiovascular Medical Devices are addressed in the following posts:

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Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa

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Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

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

SOURCE INFORMATION

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Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Abiomed shares lower as FDA panel votes to retain Class III status for Impella

Quick Facts

Company founded in 1981

Corporate Headquarters: Danvers, Massachusetts

European Division: Aachen, Germany

Number of Employees: 400+

NASDAQ Symbol: ABMD

Only company with FDA approval for heart recovery

First and only World’s Smallest Heart Pump

First Total Artificial Heart

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Implantable Synchronized Cardiac Assist Device Designed for Heart Remodeling: Abiomed’s Symphony

Quick Facts

Company founded in 1981

Corporate Headquarters: Danvers, Massachusetts

European Division: Aachen, Germany

Number of Employees: 400+

NASDAQ Symbol: ABMD

Only company with FDA approval for heart recovery

First and only World’s Smallest Heart Pump

First Total Artificial Heart

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

Curator: Aviva Lev-Ari, PhD, RN

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

Product Advantage for Partnership with Niche Suppliers in MA

Product Advantage for Partnership with National Leader in MA

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

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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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)

This report covers the following product categories

Heart Valve Frames:

Stents:

Surgical tools:

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:

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

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

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.

Contact Us

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

Cardiology vascular surgery – The OR equipment

Arterial catheterization kit suppliers

Embolectomy catheters suppliers

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

Occlusion catheter suppliers

Billary stents

Carotid shunts suppliers

External and internal carotid shunts suppliers

Micro vascular clips suppliers

Stainless steel tunneler vascular graft suppliers

Vascular stent suppliers

Cardiopulmonary bypass vascular catheter suppliers

Catheter tip occluder suppliers

Synthetic/biological composite vascular graft suppliers

Valvulotome suppliers

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