Posts Tagged ‘Edwards Lifesciences Corporation’

First case in the US: Valve-in-Valve (Aortic and  Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices

Writer: Larry H Bernstein, MD, FCAP


Curator: Aviva Lev-Ari, PhD, RN


UPDATED on 9/24/2018

TCT: Long-Term Data Reassuring for Valve-in-Valve TAVR

New valve performs well through 3 years

by Nicole Lou, Contributing Writer, MedPage Today

Transcatheter valve-in-valve replacement had lasting benefits in a high-risk patient population requiring valve reintervention, registry data showed.

Starting with 365 patients who got valve-in-valve transcatheter aortic valve replacement (TAVR), death took its toll in 12.1%, 22.2%, and 32.7% by 12, 24, and 36 months, respectively. Stroke and repeat valve replacement had plateaued to 5.1% and 0.6% over 24 months, rising to 6.2% and 1.9% at the 36-month mark.

Valve performance was sustained the whole time, as effective orifice area had a significant boost from baseline to discharge, staying stable thereafter out to 3 years; mean gradient dropped after the procedure and similarly stayed unchanged over time, according to John Webb, MD, of St. Paul’s Hospital in Vancouver, at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Among survivors, early improvements in functional status were also maintained over the 3-year period, Webb said. Most patients started off in New York Heart Association class 3 and 4 and were reclassified as class 1 and 2 after TAVR. Quality of life also was better, as shown in improved Kansas City Cardiomyopathy Questionnaire overall summary scores: 43.1 at baseline to 70.8 at 30 days (P<0.0001), and staying stable out to 3 years.

The results were not influenced by surgical valve size, failure mode, approach, or residual gradient.

These data are “certainly reassuring out 2-3 years” but the concern lies in anticipation of lower-risk and younger patients who are expected to start getting TAVR in the future, commented Stephan Windecker, MD, of the University of Bern in Switzerland, who was a panelist at the TCT late-breaker trial session.

There are some concerns regarding coronary obstruction, Webb acknowledged. “This is true in surgical valves and it would be every bit as true in transcatheter valves, if not more so.”

Primary Source

Transcatheter Cardiovascular Therapeutics

Source Reference: Webb JG “Late follow-up from the PARTNER aortic valve-in-valve registry” TCT 2018.




UPDATED on 4/13/2014

Replacement of the Mitral Valve: Using the Edwards’ Sapien Aortic Valve Device




June 23, 2013

The following is a report of the first case in the US of both aortic and mitral valve transcatheter replacements using transfemoral devices via the transapical approach. 

It is part of a series on the cardiovascular team at the Columbia Univarsity Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation in the Partner trial.

Concomitant Transcatheter Aortic and  Mitral Valve-in-Valve Replacements Using Transfemoral Devices Via the Transapical Approach

Paradis J-M, Kodali SK, Hahn RT, George I, Daneault B, et al.
ColumbiaUniversityMedicalCenter/NewYork-Presbyterian Hospital, New York, NY fJACC:CARDIOVASCULARINTERVENTIONS  2013;6(1):94-96

Case Presentation

This is an 85 year old man with congestive heart failure (CHF) NYHA class III/IV and hemolytic anemia. He had a previous history of S. viridans bacterial endocarditis that caused severe aortic and mitral regurgitations. Both aortic and mitral valves were replaced in 2002.  A recenttTransesophageal echocardiogram (TEE) showed the left ventricular ejection fraction (LVEF) was 55%.    This was related to severe mitral regurgitation caused by a flail leaflet, and its internal diameters measured 21-23.8 mm.  There was, in addition, severe stenosis of the Carpentir-Edwards valve in the aortic position with an aortic valve area (AVA) of only 0.9 cm, which was 24 mm internal diameter measured by 3-D TEE.

Action Taken

The patient was felt to require reoperative aortic and mitral valve replacements, but he was deemed inoperable by 2 cardiothoracic surgeons.  Therefore they decided to proceed with transapical transcatheter double valve-in-valve implantation using 2 commercially available RetroFlex 3 transfemoral devices (Edwards Lifesciences, Irvine, CA).  A 26-mm Edwards SAPIEN transcatheter heart valve (THV) was placed within the Carpentier-Edwards valve in the aortic position without pre-dilatation under rapid ventricular pacing.  An Edwards SAPIEN 26-mm THV was then deployed within the Hancock modified bioprosthesis in the mitral position with a 2-step inflation technique.  TEE after deplonment of both valves showed excellent function.  The new aortic prosthetic valve had an AVA of 2.08 cm, peak and mean gradients of 12 and 6 mm Hg, respectively, and no aortic insufficiency.  The mitral valve area was 1.65 cm, and there was only trace mitral regurgitation.

Figure 1.TEE Showing the Mitral Bioprosthetic Valve

Transesophageal echocardiogram (TEE) demonstrating (A) color Doppler through the mitral bioprosthetic  valve. Severe intraprosthetic  mitral regurgitation caused by a flail leaflet generates an eccentric regurgitant jet (see Online Video1).The effective regurgitant orifice was calculated  to be 0.42cm. (B) Measurements of the internal dimensions of the mitral bioprosthesis using 3-dimensional reconstruction imaging.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Figure 2.TEE Showing  the Aortic Bioprosthetic Valve.

Transesophageal echocardiogram (TEE) showing (A) planimetry of the orifice and (B) measurement of the internal diameter of the aortic bioprosthesis.

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

Figure 3.The 4 Prosthetic Heart Valves.

Final fluoroscopic images showing the 4 prosthetic heart valves (Hancock modified,Carpentier-Edwards, and 2 Edwards SAPIEN transcatheter heart valves) in different angulations

Concomitant Transcatheter Aortic and Mitral Valve-in-Valve Repla

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This image was selected as a picture of the we...

This image was selected as a picture of the week on the Farsi Wikipedia for the 46th week, 2010. (Photo credit: Wikipedia)

legend for transesophageal echocardiogram of m...

legend for transesophageal echocardiogram of mitral valve prolapse (Photo credit: Wikipedia)

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Diagram of the human heart 1. Superior Vena Cava 2. Pulmonary Artery 3. Pulmonary Vein 4. Mitral Valve 5. Aortic Valve 6. Left Ventricle 7. Right Ventricle 8. Left Atrium 9. Right Atrium 10. Aorta 11. Pulmonary Valve 12. Tricuspid Valve 13. Inferior Vena Cava (Photo credit: Wikipedia)

An artificial heart valve may be used to surgi...

An artificial heart valve may be used to surgically replace a patient’s damaged valve. (Photo credit: Wikipedia)

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Mitral valve prolapse 2 (Photo credit: Wikipedia)

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Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

Writer: Larry H Bernstein, MD, FCAP


Curator: Aviva Lev-Ari, PhD, RN

Significant, defined as a greater than 50 percent narrowing, left main coronary artery disease (LMCAD) is found in 4 to 6 percent of all patients who undergo coronary arteriography [1]. When present, it is associated with multivessel coronary artery disease (MVCAD) about 70 percent of the time [2,3].

Most patients are symptomatic and at high risk of cardiovascular events, since occlusion of this vessel compromises flow to at least 75 percent of the left ventricle, unless it is protected by collateral flow or a patent bypass graft to either the left anterior descending or circumflex artery. Studies performed before revascularization with coronary artery bypass graft surgery (CABG) became the standard of care revealed a poor prognosis for these patients, with three-year survival as low as 37 percent [4]. CABG, when directly compared to medical therapy, is associated with significantly better cardiovascular outcomes, including mortality [5].

Percutaneous coronary intervention (PCI) with stenting has generally been restricted to such patients considered inoperable or at high risk for CABG, or with prior CABG and at least one patent graft to the left anterior descending or circumflex artery (so-called “protected” left main disease). Graft patency is important in this setting in the event of acute or late closure after PCI. However, evidence is increasing to support the use of PCI with stenting in some cases. (See ‘PCI versus CABG’ below.)

Asymptomatic patients with left main lesions felt to not be hemodynamically significant should be managed with preventative therapies. Patients with anginal symptoms attributable to lesions elsewhere should be managed with therapies similar to those used in other patients with coronary artery disease. (See “Overview of the care of patients with stable ischemic heart disease”.)

This topic will discuss most aspects of the management of patients with LMCAD. The approach to patients with multivessel coronary artery disease without LMCAD is discussed elsewhere. (See “Bypass surgery versus percutaneous intervention in the management of stable angina pectoris: Recommendations”.)



Management of significant left main coronary disease before and after trans-apical transcatheter aortic valve replacement in a patient with severe and complex arterial disease.


Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.


We report the case of an 81-year-old woman with symptomatic severe aortic stenosis, extremely significant peripheral arterial disease, and obstructive coronary artery disease who underwent percutaneous coronary intervention via a transaxillary conduit immediately before a trans-apical transcatheter aortic valve replacement performed with a transfemoral device. After deployment of the transcatheter heart valve, there was a left main coronary obstruction and the patient required an emergent PCI. This multifaceted case clearly underlines the importance of a well functioning heart team including the interventional cardiologist, the cardiovascular surgeon, and the echocardiographer. © 2013 Wiley Periodicals, Inc.

Copyright © 2013 Wiley Periodicals, Inc.

This is an interesting surgical case presented by the Columbia University Cardiovascular Surgery team, illustrating the importance of combined team skills in the most difficult of cases.  It is part of a series on cardiovascular surgery.

Management of significant left main coronary disease before and after trans-apical transcatheter aortic valve replacement in a patient with severe and complex arterial disease.

Paradis JM, George I, and Kodali S
Catheterization and Cardiovascular Interventions  (2013)


Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN transcatheter heart valve (THV) (Edwards Lifesciences, Irvin, CA) has been shown to reduce mortality when compared to medical therapy alone for patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement due to multiple co-morbidities. The Edwards SAPIEN THV, sizes 23 and 26 mm, and the RetroFlex 3 transfemoral delivery system, have been recently approved by the US Food and Drug Administration (FDA) for commercial use outside of the PARTNER clinical trial for patients considered inoperable.  However, an alternative site needs to be selected for patients with peripheral arteries inadequate for transfemoral TAVR.  Although not fully validated, the transapical approach or the transaortic route using a balloon expandable THV,  appears to be appropriate for this specific purpose.  Significant coronary artery disease (CAD) is often found in patients with severe aortic stenosis. in > 50% of patients with aortic stenosis over 70 years of age and in > 65% of patients who are  over 80 years of age. There is no established guideline for managing significant CAD in the context of TAVR, including the appropriate revascularization strategy as well as the timing of interventions.

Case Report

An 81-year-old woman  presented with symptomatic severe aortic stenosis, extremely significant peripheral arterial disease, and obstructive coronary artery disease. She had a six-month history prior to admission of progressive exertional shortness of breath and fatigue, and a long history fo hypertension, hyperlipidemia, obesity, and severe peripheral vascular disease.  In 2003, she underwent a coronary artery bypass graft (CABG) surgery, with grafting of the left internal mammary artery (LIMA) to the left anterior descending (LAD) artery, a saphenous vein graft (SVG) to the first obtuse marginal (OM) branch, and a SVG to the right coronary artery (RCA). Due to associated severe mitral regurgitation, a mitral valve ring annuloplasty was also performed. A transthoracic echocardiogram (TTE) revealed severe aortic stenosis with a peak gradient across the aortic valve of 63 mm Hg, a mean gradient of 39 mm Hg, and an aortic valve area of 0.8 cm2.  The left ventricular ejection fraction (LVEF) was 64% while the pulmonary artery systolic pressure was measured at 28 mm Hg.  Extreme calcification and tortuosity precluded the advancement of any wire, catheter, or sheath, contributing to two attempts at cardiac catheterization prior to transfer with a total occlusion of the distal abdominal aorta, at the level of the aorto-iliac bifurcation, and the left main, proximal LAD, proximal left circumflex, and the proximal RCA all had greater than 70% coronary lesions. In addition, ostial total occlusions were seen in both SVGs.
left main coronary artery
After transfer, a cardiac catheterization through the right radial artery was attempted without success due to calcification and tortuosity in the arterial bed.  An 80% distal left main lesion was clearly identified with a Judkins left 3.5 guiding catheter.  There was non-flow limiting coronary disease in the left circumflex and competitive retrograde flow seen in the LIMA graft, but they still were unable to cannulate the RCA and the SVGs. It was determined that the patient was inoperable, on grounds of her significant frailty, reoperative status and overall comorbid state (Society of Thoracic Surgeons (STS) risk score of 11%). Furthermore, due to the occlusion of the distal aorta, the patient was unsuitable for a TAVR via the transfemoral approach.
They chose to approach her PCI via a conduit on the right axillary artery and perform a concomitant TAVR from a trans-apical approach due to the serious limiting condition of the patient.  She underwent percutaneous coronary intervention via a transaxillary conduit immediately before a trans-apical transcatheter aortic valve replacement performed with a transfemoral device.  Excellent flow from the conduit was noted. A 7 French (Fr) sheath was connected to the end of the conduit, which was kept long to allow better maneuverability (Fig. 1). A Rosen wire was passed with some difficulty to the aortic root, and was switched to a stiff wire in an attempt to straighten the vessel.
PowerPoint Presentation
Fig. 1. Transaxillary conduit used during the procedure. A 7 French sheath was connected to an 8 mm dacron graft, which was previously sewn to the axillary artery.
After deployment of the transcatheter heart valve, there was a left main coronary obstruction and the patient required an emergent PCI.  This multifaceted case clearly underlines the importance of a well functioning heart team including the interventional cardiologist, the cardiovascular surgeon, and the echocardiographer. A Xience
V everolimus eluting stent 3.5 mm  18 mm was implanted starting 2 mm distal to the ostium of the left main, extending in the proximal portion of the left circumflex artery. After one post-dilatation with a non-compliant balloon, the final angiographic result was excellent.
They used a Retroflex 3 transfemoral delivery sheath to perform the trans-apical TAVR. They estimated the size and length of the ventricular cavity, and then placed markers on the delivery sheath (prior to insertion) indicating the appropriate length of sheath to remain outside the heart (Fig. 2).
PowerPoint Presentation
Fig. 2. Marker placed on the RetroFlex 3 transfemoral sheath to safely guide its insertion inside the left ventricular cavity during the trans-apical transcatheter aortic valve replacement.
A 23 mm Edwards SAPIEN valve was selected and deployed under fluoroscopic and transesophageal echocardiographic guidance. Immediately after deployment, turbulent flow was noted within the left main with the color Doppler on TEE, indicating a new obstruction of the left main, which a left coronary angiogram showed to be a severe proximal lesion.  Through the trans-axillary conduit, a  guiding catheter was laboriously brought in the ascending aorta and cannulated the left main artery which permitted a predilation and a stent insertion in the ostial portion of the left main.  She was discharged to a rehabilitation facility 7 days after the procedure.
On follow-up TTE, the LVEF was 55% without any significant wall motion abnormality. There was no aortic regurgitation, and the peak and mean gradients were 14.9 mm Hg and 8.0 mm Hg, respectively. The patient is still doing well more than 6 months after the procedure. She is now in NYHA class 2 and has not had any recurrent hospitalization for congestive heart failure.
This report is a case of a complex percutaneous coronary intervention of the left main coronary artery via a right axillary conduit followed immediately by an off label commercial transapical TAVR using the Retro-Flex 3 trans-femoral introducer sheath, complicated finally by a new left main coronary obstruction mandating another PCI. It is the first description of a TAVR procedure preceded and followed by a left main trans-axillary PCI. The role of TEE (color Doppler) in the diagnosis of a very rare TAVR complication is also noteworthy. In a recent meta-analysis of 3,519 patients from 16 studies using the Valve Academic Research Consortium (VARC) definitions, the pooled estimate rate of coronary
obstruction following TAVR was only 0.7%. Obviously, the early recognition and treatment of this hazard is imperative.
The surgical management of this patient also warrants discussion. The hybrid surgical approach of accessing the axillary artery via a conduit provides numerous advantages:
(1) the ascending aorta, coronaries, and aortic valve are easily accessible;
(2) transition to cardiopulmonary bypass or extra-corporeal membrane oxygenation, if needed, is quick; and
(3) long-term morbidity is minimal for the patient when compared to aorto-iliac, aortic, or femoral conduits.
Finally, the heart team approach not only allowed the realization of a difficult coronary
stent implantation through an unusual transaxillary graft followed by a transapical TAVR in a patient with significant peripheral arterial disease, but also permitted the early  recognition and management of a potentially fatal left main obstruction. Considerations such as team-based care, close communication between the different specialties
involved and careful planning for outlining management of potential complications are therefore essential for the success of a TAVR program.


 1. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607.
2. Iung B. Interface between valve disease and ischaemic heart disease. Heart 2000;84:347–352.
3. Wenaweser P, Pilgrim T, Guerios E, Stortecky S, Huber C, Khattab AA, et al. Impact of coronary artery disease and percutaneous coronary intervention on outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
EuroIntervention 2011;7:541–548.
4. Genereux P, Head SJ, Van Mieghem NM, Kodali S, Kirtane AJ, Xu K, et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: A weighted meta-analysis of 3,519 patients from 16 studies.
J Am Coll Cardiol 2012;59:2317–2326.
Three coronary artery bypass grafts, a LIMA to...

Three coronary artery bypass grafts, a LIMA to LAD and two saphenous vein grafts – one to the right coronary artery (RCA) system and one to the obtuse marginal (OM) system. (Photo credit: Wikipedia)

heart with coronary arteries

heart with coronary arteries (Photo credit: Wikipedia)

Micrograph of an artery that supplies the hear...

Micrograph of an artery that supplies the heart with significant atherosclerosis and marked luminal narrowing. Tissue has been stained using Masson’s trichrome. (Photo credit: Wikipedia)

Other Related articles on this topic published on this Open Access Online Scientific Journal, include the following:

Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment

Aviva Lev-Ari, PhD, RN 6/6/2012


Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons


Lev-Ari, A. 8/13/2012 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. 7/18/2012 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia


Lev-Ari, A. 6/22/2012 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. 6/19/2012 Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market


Lev-Ari, A. 6/22/2012 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


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Lev-Ari A. 4/6/2012.  Investigational-devices-edwards-sapien-transcatheter-heart-valve. 


Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity”    http://pharmaceuticalintelligence.com/2013/01/08/cardiac-surgery-theatre-in-china-vs-in-the-us-cardiac-repair-procedures-medical-devices-in-use-technology-in-hospitals-surgeons-training-and-cardiac-disease-severity/

Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI    http://pharmaceuticalintelligence.com/2013/03/10/acute-chest-painer-admission-three-emerging-alternatives-to-angiography-and-pci/

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

Reporter: Aviva Lev-Ari, PhD,RN


UPDATED on 5/27/2014

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

May 23, 2014

PARIS, FRANCE — Some of the longest follow-up for the first transcatheter aortic-valve implantations (TAVI) ever performed confirm earlier observations that the biggest threat to survival in TAVI-implanted patients remains their comorbidities and not problems related to their valves, regardless of valve type. More surprising, some of the procedural issues that preoccupy interventionalists and surgeons today did not emerge as important in this longer-term follow-up.

Presenting three- and five-year data from the UK TAVI registry in a press conference here at EuroPCR 2014 , Dr Neil Moat (Royal Brompton Hospital, London, UK) pointed to what he called “biphasic” survival curves. In the first few months after valve implantation, there is a steep drop in survival, he noted. Thereafter, the curve becomes significantly less steep, mirroring the survival curves typically seen in older patients who have undergone surgical valve replacement.

“In the first six months, you have quite a dramatic attrition of patients, then mortality falls to about 6% of patients per year,” he said. “What this is telling us is that patients undergoing TAVI are not dying of TAVI-related factors.”

The UK TAVI registry contains prospectively collected data from 100% of all consecutive transcatheter aortic-valve replacement (TAVR) patients treated since January 1, 2007. The current analysis includes 870 early patients whose mortality status was ascertained in July 2013.

In all, 62% of TAVR-treated patients were alive at three years, while just under half—48.4%—were still alive at five years.

Dr Neil Moat [Source: EuroPCR]

In multivariable analyses, the strongest baseline predictor of mortality at three years was

  • creatinine >200 µg/mmol, followed by
  • presence of atrial fibrillation,
  • chronic obstructive pulmonary disease (COPD), or a
  • high EuroSCORE (>18.5).

Of note, device- or procedure-related characteristics that typically get a lot of attention at interventional meetings were not significant predictors of late survival. For example,

  • 12.7% of patients still alive at three years had had moderate/severe aortic regurgitation at the time of their procedure, compared with
  • 14.9% of patients who’d died, but the difference was not statistically significant. Likewise,
  • permanent pacemaker implantation had been performed in 16.2% of patients still alive at follow-up and in
  • 19.3% of patients who died, again a nonsignificant difference.

Not surprisingly,

  • more transfemorally treated patients were alive at three years than
  • patients treated via a nontransfemoral procedure (64.3% vs 55.7%, p=0.017).

Roughly the same number of patients received the

  • Edwards Sapien device in the early days of the TAVI registry (410) as received the
  • Medtronic CoreValve (452).

By three years,

  • 40.7% of Sapien-treated patients had died, compared with
  • 35.4% of CoreValve-treated patients (p=0.078).
“CoreValve had a trend toward better survival, but I wouldn’t want to overinterpret that,” Moat cautioned. These are preliminary data, he stressed, but added, “There is a trend there that needs looking at” when the registry has more patients, with more follow-up.

One of the theories put forward in other sessions at EuroPCR is that the higher pacemaker-implantation rate with CoreValve might, in fact, help bump up survival rates with this device.

“It’s an interesting hypothesis,” Moat said. “But I don’t think we have any data to support that hypothesis, either here or in any other study. I think if there were an effect of early pacemaker implantation it would be in this first [six-month] phase. Some people are concerned that the early attrition is sudden death because of late heart block occurring two, three, or four months after the procedure. So if you are having pacemakers implanted more frequently, you are being protected from that, but I think our data strongly suggest that pacemaker implant does not affect long-term survival.”

Moat disclosed being a consultant for Medtronic.


UPDATED on 2/9/2014

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

January 28, 2014 6:29 AM 

Business Wire

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

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

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

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

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

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

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

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

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


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

For additional discussion go to 

Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly


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

Evidence for TAVI Questioned

By Chris Kaiser, Cardiology Editor, MedPage Today

Published: July 31, 2012

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The authors reported they had no relationships to disclose.

Primary source: BMJ

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

Reporter: Aviva Lev-Ari, PhD, RN


UPDATED ON 8/23/2016

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

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



For Immediate Release

August 18, 2016


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

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

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

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

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

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

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

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

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

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


Transcatheter Aortic Valve Implantation (TAVI): Risky  and Costly

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

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

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

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

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

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


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

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

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


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

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

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

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

52wk Range: 61.59 – 106.94

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

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

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

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

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

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

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

Transcatheter aortic valve implantation (TAVI): risky and costly

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

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

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

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

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


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

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

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

Approval processes

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

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

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

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

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

What the evidence shows

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

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

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

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

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

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

Disclosure of interests

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

Practice beyond the evidence

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



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

Inoperable patients

High risk patients* Pivotal trial† Continued access study‡

TAVI AVR P value TAVI Control P value TAVI Control

No of patients 348 351 179 179 41 49

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

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

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

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

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

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

§ Kaplan-Meier estimates.

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

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Global Supplier Strategy for Market Penetration &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

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











US comparison

MA comparison

Cardiology & Vascular Surgery Tools and Devices in use

Global Suppliers

US Suppliers

Market share

Global ratio


MA Suppliers

Market share

Global ratio


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












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 = D*E*$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


External and internal carotid shuntsPRC = 3.7 Bard Electrophysiology www.bardep.comLowell

Lemaitre Vascular, Inc. www.lemaitre.com


Micro vascular clipsPRC = 3.7 Lemaitre Vascular, Inc. www.lemaitre.comBurlington

Life Instrument Corporation www.lifeinstruments.com


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


Lemaitre Vascular, Inc. www.lemaitre.com


Clinical Instruments Intl., Inc.


Smiths Medical ASD, Inc


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.


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.


Boston Scientific Corporation www.bostonscientific.comNatick
Occlusion catheterPRC = 2.4 Lemaitre Vascular, Inc. www.lemaitre.comBurlington

Telemed Systems Inc. www.telemedsystems.com


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



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



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Curator: Aviva Lev-Ari, PhD, RN

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

Edwards Lifesciences Reports Strong 2012 Fourth Quarter Results

February 5, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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




Read more: Edwards Lifesciences Reports Strong Fourth Quarter Results – FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/edwards-lifesciences-reports-strong-fourth-quarter-results#ixzz2K3FNImH7

History of Edwards Lifesciences

 Edwards Lifesciences’ roots date to 1958, when Miles “Lowell” Edwards set out to build the first artificial heart.

Edwards was a 60-year-old, recently retired engineer holding 63 patents in an array of industries, with an entrepreneurial spirit and dreams of helping patients with heart disease.  His fascination with healing the heart was sparked in his teens, when he suffered through two bouts of rheumatic fever, which can scar heart valves and eventually cause the organ to fail.

With a background in hydraulics and fuel pump operations, Edwards believed the human heart could be mechanized.  However, when he presented the concept to Dr. Albert Starr, a young surgeon at the University of Oregon Medical School, the idea was met with hesitation.  Instead, Starr encouraged Edwards to focus first on developing an artificial heart valve, for which there was an immediate need.  

After only two years, the first Starr-Edwards mitral valve- which is not longer available for sale – was designed, developed, tested, and successfully placed in a patient.  Newspapers around the world reported on what they termed a “miraculous” heart surgery.  

This innovation spawned a company, Edwards Laboratories, which set up shop in Santa Ana, Calif. — not far from where Edwards Lifesciences’ global headquarters is located today.

Edwards Lifesciences’ heart valve expertise has led to the development of one of the most exciting opportunities in the cardiovascular field – transcatheter heart valve replacement.  The specially-designed valve and delivery system*  is being evaluated in clinical studies in which high-risk patients receive a valve replacement without traditional open-heart surgery and while their heart continues to beat.  Clinicians replace a patient’s aortic valve via a catheter inserted into a small incision in either the leg or between the ribs.  Edwards Lifesciences’ leadership in transcatheter heart valve replacement includes a commitment to rigorous scientific study of the procedure and to extensive clinician training and education.

Consistent with this effort to explore less invasive surgery, the company is committed to providing tools for minimally invasive cardiac surgery that allow cardiac surgeons to perform heart valve operations through small openings, or “ports,” in the spaces between the ribs.


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

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

This study is currently recruiting participants.

Verified May 2012 by Edwards Lifesciences

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


Edwards Lifesciences

Information provided by (Responsible Party):

Edwards Lifesciences

ClinicalTrials.gov Identifier:



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

Condition Intervention Phase
Symptomatic Severe Aortic Stenosis Device: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: AVR with a surgical heart valveDevice: TAVR Implantation of the Transcatheter Aortic Valve ProsthesisDevice: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis Phase 3
Study Type: Interventional
Study Design: Allocation: RandomizedEndpoint Classification: Safety/Efficacy StudyIntervention Model: Parallel AssignmentMasking: Open LabelPrimary Purpose: Treatment
Official Title: The PARTNER II Trial “Placement of AoRTic TraNscathetER” Valves Trial” (US) [Edwards Study 2010-12]


Unparalleled Commitment to Research

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

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

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

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

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

Core Facilities

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

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

Complete catheterization including hemodynamic monitoring with bi-plane fluoroscopic imaging



MicroPET (positron emission tomography)

MicroSPECT (single positron emission computed tomography)

OCT (optical computed tomography)

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

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

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

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


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

Edwards Lifesciences Corporation


To be held on Thursday, May 10, 2012


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

Allergan, Inc.

Masimo Corp.

Becton Dickinson & Co.

Medtronic, Inc.

Boston Scientific Corp.

PerkinElmer, Inc.

C. R. Bard, Inc.

ResMed, Inc.

CareFusion, Inc.

St. Jude Medical, Inc.

Covidien plc

Stryker Corp.

Gen-Probe, Inc.

Thoratec Corp.

Hospira, Inc.

Varian Medical Systems, Inc.

Illumina, Inc.

Zimmer Holdings, Inc.

Integra Lifesciences Holding Corp.



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

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

                                                                        2011     2011     2010    2009

                                                                        Actual Target Actual Actual

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

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

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



Comparison of Cumulative Five Year Total Stock Return






Edwards Life Sciences












Morgan Stanley  Health Care Products






http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.26

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


CEO TDC (Average) (in thousands)

Most Recent FY

Last 3 FYs

Last 5 FYs

2011 Comparatoe Group

90th Percentile




75th Percentile








25th Percentile




Edwadrs Lifesciences








http://ht.edwards.com/sci/edwards/sitecollectionimages/edwards/investorrelations/2012edwardsproxy.pdf p.29

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

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

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

Last 3 FYs 55.6%, maximum percentile

Last 5 FYs 37.3%, maximum percentile

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

Last 3 FYs 18.9%

Last 5 FYs 8.5%

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

On June 14, 2012:

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


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


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

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

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

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

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

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

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

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

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



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

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

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

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

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


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

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


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

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


FDA Panel

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

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

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

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


Medicare to Cover Edwards’ Sapien Heart Valve

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

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

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

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

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


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

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

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


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

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

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

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

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


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

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

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

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



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

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

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

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