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Posts Tagged ‘Edwards’


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

and

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.

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75261?xid=nl_mpt_ACC_Reporter_2018-09-23&eun=g5099207d2r

 

UPDATED on 4/13/2014

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

https://pharmaceuticalintelligence.com/2014/04/10/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
http://dx.doi.org/10.1016/j.jcin.2012.07.018

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

Related articles in Pharma Intelligence

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

Aviva Lev-Ari, PhD, RN, 7/11/2012

https://pharmaceuticalintelligence.com/2012/07/11/implantable-synchronized-cardiac-assist-device-designed-for-heart-remodeling-abiomeds-symphony/

Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization

Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/5_04_2013/bernstein_lev-ari/Bioengineering_of_Vascular_and_Tissue_Models

Foreseen changes in Guideline of Treatment of Cardiogenic Shock with Intra-aortic Balloon counterPulsation (IABP)

Evidence for Overturning the Guidelines in Cardiogenic Shock

Clinical Indications for Use of Inhaled Nitric Oxide (iNO) in the Adult Patient Market: Clinical Outcomes after Use, Therapy Demand and Cost of Care

Aviva Lev-Ari, PhD, RN, 6/3/2013

Aviral Vatsa PhD MBBS, 1/4/2013

Clinical Trials Results for Endothelin System: Pathophysiological role in Chronic Heart Failure, Acute Coronary Syndromes and MI – Marker of Disease Severity or Genetic Determination?

Aviva Lev-Ari, PhD, RN, 10/19/2013

https://pharmaceuticalintelligence.com/2012/10/19/clinical-trials-results-for-endothelin-system-pathophysiological-role-in-chronic-heart-failure-acute-coronary-syndromes-and-mi-marker-of-disease-severity-or-genetic-determination/

Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems

Justin Pearlman MD ME PhD MA FACC, Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/

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)

Diagram of the human heart 1. Superior Vena Ca...

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)

Mitral valve prolapse 2

Mitral valve prolapse 2 (Photo credit: Wikipedia)

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Author: Michael, Ward, DVM

I recently found a report, written by Mark Hollmer and published 28 November, 2012 by Fierce Medical Devices

http://www.fiercemedicaldevices.com/signup?sourceform=Viral-Tynt-

entitled, “Edwards’ mitral heart valve wins Chinese SFDA nod”.

Though I wonder why Edwards would be taking a more than 30 year-old medical device to China – only Edwards’ business leaders could answer that – I was stuck by one small paragraph that led to this writing.

“Edwards, like many device companies, has turned to China for new growth opportunities and the country factors into its long-term growth plans. Known for heart valves and hemodynamic monitoring devices, Edwards has also propelled U.S. growth with its Sapien transcatheter aortic heart valve, which won FDA approval earlier this fall to treat a larger class of patients.”

This discussion will address the current trend of Western companies attempting to penetrate China’s medical device market. As one who is often asked to speak at public meetings on this topic, I have given frequent and serious reflection on my experiences with and knowledge of this topic.

The uninitiated Western medical device companies may not realize that China is very much different from other major countries, in the areas of

  • marketing/sales,
  • regulatory affairs,
  • clinical research, and
  • hospital practices.

Historically, SFDA has been active since the 1990’s; however, their initial focus was limited to understanding and approving pharmaceuticals. Thus, SFDA’s

  • regulations,
  • extent of product and therapeutic knowledge, and
  • GCP certification programs

have been primarily focused on drugs. With the exception of the counterfeit medicine epidemic, global pharmaceutical companies have become well entrenched and enjoy a strong presence in China’s hospitals. That does not mean they are making great profits.

Counterfeit drug enterprises in China have steadily grown into a lucrative opportunity since the 1990s. Often supported by local government and Chinese Military investment, counterfeit drug manufacturing plants can be rapidly set up and also re-established, if subjected to raids by SFDA officials. These fake medications have found their way into China’s pharmacies and hospitals, and now are a threat to the United States. The loss of bona fide sales as well as the money required to fight this criminal element significantly erodes the profits of major pharmaceutical companies.

In and above the aforementioned challenge to global pharmaceutical companies, all biomedical companies must share a considerable portion of any given patient population with Chinese Traditional Medicine (CTM). CTM has enjoyed centuries of development and use and it is an integral part of China’s society. Medical schools and hospitals teach and offer CTM therapies. Given the paucity of health insurance among the majority of China’s population and limited disposable income to pay for expensive medical treatments, CTM offers an attractive alternative – one that is deeply entrenched within the culture and also easily affordable. For reasons to which I will allude later, CTM lends itself to a culture that readily accepts anecdotal evidence and rarely scrutinizes medical therapies for compelling clinical evidence.

Medical devices have their own unique challenges to address. Initially, many of them are not readily apparent to any neophyte company that expects ‘business as usual’ when introducing products to China. Unlike Japan, where one of the biggest barriers to market entry rests in dealing with a well-organized, challenging, and complex regulatory authority, SFDA is a ‘work in progress’. China is the only country, of which I am aware, where the regulatory authority (SFDA) has asked experts in global companies for helpful guidance on the approval and oversight of medical devices. Couple that with the national governments focus on making it easier for Chinese medical device companies to access the market, and it’s easy to understand why several large home-born enterprises, such as Microport Medical, enjoy large shares of the domestic market for most indications.

For many years, and even today, many companies refuse to go to China for fear of having their technology reverse engineered and copied. This fear is fueled by China’s lack of effective laws on intellectual property (IP). Even where laws do exist, they are rarely enforced. This fear on the part of Western companies is irrational, which is why the major global medical device companies and many smaller organizations, including Edwards LifeSciences, have concluded that threats to their IP are no more an issue in China than in any other region of the world.

That is not to say copycat devices don’t exist in China. Many observers are curious as to how these large domestic medical device companies in China could have product portfolios that closely replicate those of the major global companies. To illustrate this point – during the 1990s, I knew a Chinese woman in Southern California who worked in QA and, therefore, had access to drawings, test results, and manufacturing processes for any of her current company’s product portfolios. Her open confession to me was that, after another year or so, she planned to go back to China to establish her own catheter company, using all the knowledge and information she had gathered in her job. Western media have uncovered a lot of copying of company proprietary information by Chinese citizens who find jobs in the USA or Europe. Many ‘industrial spies’ are highly qualified engineers and scientists who make valuable contributions to all aspects of product development. In spite of their devotion to product development, one can understand their culturally-inbred insensitivity toward issues of confidentiality and intellectual property.

Some readers might be thinking right now, “Damned if you do!” (going to China) and “Damned if you don’t!” (opting to stay in a protective mode outside China). Some might conclude that, if Western countries open up their doors to foreign engineers and scientists, no IP is safe. However, one only has to look at WL Gore (Flagstaff AZ), which experienced an American-bred and educated manufacturing ‘associate’ relocating down the mountain to Phoenix to establish a company that was alleged to have incorporated biomaterials, knowhow, and manufacturing processes inherent to Gore. Though the latter is uncommon, it does underscore the point that industrial espionage is not just a China-based challenge; however, in most Western countries, rigorous enforcement of strict IP laws is quite effective in keeping ‘copycat’ medical devices, including those that originate in China, off the market. Given this perspective, avoiding China only for fear of IP threats is irrational.

In September 2012, in Northern California, I met with a VP of International Business for one of the largest of China’s domestic medical device companies. I was curious about his company having no presence in the U.S. market and their international focus on African and South American countries – both regions being weak in enforcing laws on IP. Given his company’s limited global focus and his admission that the company leadership in Shanghai only understood China’s processes and had no appreciation of or interest in appropriate development and expensive testing of medical devices sufficient to achieve CE Mark or 510(k) clearance, Western medical device business leaders can breathe easy about the prospect of a company in China threatening market share in Europe, USA and many other Western countries with copycat devices.

This is just one of several instances where China’s culture and laws are deeply entrenched in the medical device community, resulting in unique perspectives and practices. Some of these differences and limitations make it very difficult for China’s physicians to compete with their Western counterparts in such areas as publishing in Western peer-reviewed medical journals and in carrying out quality research with medical devices. A significant challenge for Western medical device companies is to assure that their China-trained customers have sufficient skills to use their devices. Two-day training programs for physicians have proven to be quite ineffective.

There are many endemic factors, which contribute to the lack of sufficient technical skill and therapeutic proficiency on the part of China’s medical device users. Some of these are

(a) strong tendency to be dogmatic and carry on with older therapeutic approaches (justification is based on having treated large numbers of patients with long-established methods);

(b) hospital hierarchical management style, with older physicians at the top who direct all staff members to propagate older methods;

(c) medical school training does not include experience with newer medical devices;

(d) Western medical devices are often sold at Western prices, leaving so many uninsured patients unable to pay for these therapies (limited use of Western devices); and,

(e) the role of CTM further erodes opportunities to get valuable experience.

Edwards LifeSciences may enjoy early market penetration with a 30-year-old heart valve. Most companies initially focus on

  • Beijing,
  • Shanghai,
  • Guangzhou and
  • a few other major cities,

where more patients have health insurance and/or sufficient cash to pay for expensive treatments. But, to gain major market share, prices would have to come down dramatically, something many multi-national medical device companies are reluctant to consider.

The above comments are only a cursory reflection of some of the key challenges facing a company interested in the medical device market in China. I have not mentioned the unique challenges for

  • marketing and
  • distribution or the rather unique approach one must adopt to
  • sponsor and manage clinical trials in China.

A STORY OF LAGGING BEHIND:

For more than a decade, medical device applications, modernization, and market expansion in China have lagged well behind a more mature pharmaceutical domain. Compounding this is another gap created between a hierarchical, dogmatic, and historically/culturally-entrenched medical community and those components of China’s society (examples are, IT, capitalism, banking, fashion) that have dramaticall expanded, modernized, and brought economic prosperity. I believe that the aforementioned gaps have narrowed in recent years and can be increasingly narrowed such that many Western medical devices will find a formidable market presence in China.

Other related articles on Medical Devices for Cardiac Repair published on this Open Access Online Scientific Journal. include the following:

August 7, 2012 – Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

August 2, 2012 – Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

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

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

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

1/29/2013 — Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve

https://pharmaceuticalintelligence.com/2013/01/29/direct-flow-medical-wins-european-clearance-for-catheter-delivered-aortic-valve/

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

https://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/

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

https://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

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Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 6/22/2017

  • by Nicole Lou, Reporter, MedPage Today/CRTonline.org June 21, 2017

Action Points

  • Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
  • Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

SOURCE

1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry

https://www.medpagetoday.com/Cardiology/CHF/66173?xid=nl_mpt_DHE_2017-06-22&eun=g99985d0r&pos=1

UPDATED on 11/24/2013

Second Generation Transcatheter Aortic Valve Shown to Successfully Address TAVR Complications

Results of the REPRISE II trial reported at TCT 2013
November 4, 2013
heart valve repair hybrid or cath lab reprise II boston scientific lotus tct
November 4, 2013 — In a clinical trial of the Boston Scientific Lotus valve, a second-generationtranscatheter aortic valve, the device demonstrated low rates of complications that are sometimes seen in transcatheter aortic valve replacement (TAVR), including challenges with positioning, post-procedure paravalvular aortic regurgitation, vascular complications and stroke.
The findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
The valve studied in REPRISE II is fully retrievable and repositionable with an adaptive seal intended to minimize paravalvular regurgitation, a complication that has been associated with higher mortality among patients undergoing TAVR. In this prospective, single-arm, multicenter study, symptomatic patients at high risk for surgery received the Lotus valve to treat calcific aortic stenosis.
The trial enrolled 120 patients; mean age was 84.4±5.3 years, 56.7 percent were female and 75.8 percent were considered New York Heart Association (NYHA) Class III or IV. The mean Society of Thoracic Surgeons score was 7.1±4.6 percent and all patients were confirmed by their site heart team to be at high risk for surgery due to frailty or associated comorbidities.
The valve was successfully implanted in all 120 patients with valve repositioning and retrieval performed as needed. There was no embolization, ectopic valve deployment or need for implantation of a second prosthetic valve.
The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days compared to a performance goal of 18 mmHg; the primary safety endpoint was 30-day mortality. The primary device performance endpoint was met with a 30 day mean aortic valve pressure gradient of 11.5±5.2 mmHg; mean effective orifice area was 1.7±0.4 cm2.
All cause mortality and disabling stroke were low at 30 days (4.2 percent and 1.7 percent, respectively). Additional clinical event rates were consistent with those reported for other valves. Aortic regurgitation at 30 days was negligible in 99 percent of patients (78.3 percent none, 5.2 percent trace and 15.5 percent mild). The total stroke rate, disabling and non-disabling, was 5.9 percent, which is the same as the rate as the Edward’s Sapien valve’s performance in the PARTNER trial.
“These findings suggest this valve, which is a differentiated, second generation TAVR device, will be a valuable addition for the treatment of severe aortic stenosis,” said Ian Meredith, MBBS, Ph.D., director, Monash HEART, executive director, Monash Cardiovascular Research Centre, professor of medicine, Monash University in Melbourne, Australia, and lead investigator of the study.

“This is the first time the societies have ever filed for an investigational device exemption,” former ACC president Ralph Brindis is quoted as saying. “The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.”

Two medical societies jump into clinical trial effort for TAVR tech – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/two-medical-societies-jump-clinical-trial-effort-tavr-tech/2013-02-12#ixzz2Kjk7MHEi

The new trials will mean that reimbursement will now be possible for some of these uses when patients are enrolled in the clinical trials. According to Mack, the NCD “took off-label use off the table. If you are a cynic this is good, but if you’re a practitioner this is tying your hands.”

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

According to Forbes, STS president Michael Mack told The Gray Sheet (a subscription-only publication) that the first trial will look at alternatives to transfemoral approaches in 1,000 patients who couldn’t otherwise have aortic valve surgery. There was a coordinated effort to develop a trial protocol, worked out between the CACC, STS, CMS, Edwards and the FDA. Expanded uses require an FDA label, he noted, and the only way to do that is to conduct a clinical trial with an IDE in hand.

So why would expanded TAVR uses be necessary? Well, the procedure has become very much in demand, and physicians already began pursuing off-label uses once they learned the initial TAVR procedure, Brindis told Forbes. The magazine notes that the entrance of both the STS and ACC into TAVR clinical trials greatly expands the TVT registry that they run, which tracks TAVR use in the United States to help physicians comply with Medicare’s National Coverage Decision for TAVR.

TAVR is indeed a hot space. St. Jude Medical ($STJ) won a CE mark for its Portico transcatheter heart valve late last fall, and Edwards’ Sapien competes with Medtronic‘s ($MDT) CoreValve in Europe. And smaller companies such as Micro Interventional Devices are working hard to develop surgical tools designed to enable TAVR procedures.

Brindis and Mack said that the ACC and STS worked closely with CMS,the FDA, and Edwards to develop the trial protocol. In the trial, patients not eligible for aortic valve surgery will receive TAVR through transapical and transaortic approaches and will be compared with the results of patients in the original PARTNER A trial who received TAVR through the transapical approach. Mack concedes that the trial design is not idea. “There is no perfect comparator,” he acknowledged.

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

Other experts in the field contacted by CardioBrief agreed that the challenges of trial design in this situation are quite formidable. Randomized trials are not always feasible and, in some situations, may be unethical. The IDE is an attempt to balance the need for rational clinical trials, on the one hand, and the growing pressure to perform off-label procedures. It should be noted that an important safeguard for patients remains in place: all potential TAVR patients will still need to be evaluated by both a cardiologist and a cardiac surgeon as part of the “heart team” approach mandated by the FDA and the NCD.

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

The ACC and STS are now working to gain FDA approval to perform two more studies. One would examine the role of alternative approaches in the high-risk population eligible for surgery. The second would study valve-in-valve TAVR procedures. Both studies also present challenging problems of trial design. Mack said he anticipates FDA approval of these protocols in the next few months.

Edwards agreed in principle to fund the clinical trials. An Edwards representative confirmed that the company planned to support these new trials, but the details have not yet been hammered out.

 Mack states that the power and scope of the TVT registry actually makes it easier for ACC and STS to move forward than Edwards. Further, Mack believes that some indications are like “orphan” indications that are medically but not commercially compelling.

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

Two medical societies jump into clinical trial effort for TAVR tech – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/two-medical-societies-jump-clinical-trial-effort-tavr-tech/2013-02-12#ixzz2KjheTKHN

Larry Husten, wrote on  5/04/2012 in Forbes,  The final decision earlier this week by the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement for TAVR was the latest step in a long, ongoing process that, for once, didn’t appear broken, and, in fact, represented an unusual consensus among physicians, regulators, insurers, and other involved parties In his article

Politics and Transcatheter Aortic Valve Replacement

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears:

  1. Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people.
  2. The stampede to stake a claim in a promising, highly lucrative new territory would lead to the exploitation and mistreatment of many thousands of desperately sick people.

http://www.forbes.com/sites/larryhusten/2012/05/04/politics-and-transcatheter-aortic-valve-replacement/

Scott Gottlieb, a conservative activist who is a former FDA deputy commissioner and CMS adviser, concludes that the CMS ruling means “that for costly procedures, Washington will be making more of these choices for us.” In a posting on the American Enterprise Institute’s The Enterprise BlogGottlieb writes that the decision “is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.”

http://www.forbes.com/sites/larryhusten/2012/05/04/politics-and-transcatheter-aortic-valve-replacement/

CMS  has insisted that doctors who perform the procedure have adequate training and that the hospitals where the procedures are performed have sufficient experience and adequate facilities. Perhaps Scott Gottlieb, MD would be happy to send an elderly relative for TAVR  to a local community hospital with little experience in the procedure. It was precisely to avoid this scenario that the American College of Cardiology and the Society of Thoracic Surgeons supported CMS in this coverage decision. I fail to see how anyone would benefit by widespread proliferation of TAVR by novice operators at inexperienced centers.

  • Physicians,
  • Regulators,
  • Insurers,
  • CMS,
  • Medical Device Manufactures
  • ACC, and
  • STS

will be cooperating in the College of Cardiology and Society of Thoracic Surgeons newly announced involvement in Clinical Trials on broader use of transcatheter aortic valve replacement (TAVR) procedure to include new patients that this procedure will be indicated for and CMS reimbursed.

Other aspects of the Procedure, and the role EdwardsSciences played in the development and the Industry Leadership it holds in the US, are covered in several articles on this Open Access Online Scientific Journal, including the following:

August 7, 2012 – Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

August 2, 2012 – Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

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

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

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

1/29/2013 — Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve

https://pharmaceuticalintelligence.com/2013/01/29/direct-flow-medical-wins-european-clearance-for-catheter-delivered-aortic-valve/

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

https://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/

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