FDA Approves Second Generation Heart Valve From Edwards Lifesciences Reply

The next phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had approved its second generation Sapien XT TAVR device  for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS).

Click here to read the full post on Forbes.

 

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Will Edwards Snatch Defeat From The Jaws Of Its Victory Over Medtronic? Reply

On the heels of a sweeping victory in the courts over its rival MedtronicEdwards Lifesciences is poised to dominate the TAVR (transcatheter aortic valve replacement) market– the revolutionary new catheter technology that offers some patients with life-threatening aortic valve disease an alternative to chest-splitting surgery. Although the legal wrangling is not quite over– Medtronic is appealing the decision and has requested that enforcement of the injunction be postponed– it appears likely that Edwards will ultimately achieve a broad legal and business victory.

But Edwards’ unprecedented victory also presents an unprecedented challenge to the company. While the court appears to have given Edwards everything it wished, the ultimate result could produce significant harm to Edwards’ relationship to the interventional cardiologists who are its core customers. More importantly, there is now a distinct possibility that at least for several years many people who could possibly benefit from the Medtronic technology will not be able to get it.

A Decisive Victory

In last week’s ruling a federal judge delivered a broad ruling in favor of Edwards:

Click here to read the full post on Forbes.

 

ACC And STS Break New Ground To Test TAVR For Unapproved Uses Reply

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Click here to read the entire post on Forbes.

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Slow Uptake of Transcatheter Aortic Valves: Learning from History? Reply

Transcatheter aortic valve replacement (TAVR) has been one of the most exciting new developments in cardiovascular medicine in recent years. The growing enthusiasm over TAVR led to concern and even alarm in some quarters that the introduction of TAVR would ignite a stampede of uptake, mirroring the early over-enthusiasm for similarly disruptive devices like stents and ICDs, leading to repeated cycles of criticism, investigations, and pullbacks.

Early signs now indicate that history may not be repeating itself and that the careful and deliberate introduction of TAVR may result in an entirely different pattern. Remember that ACC and STS requested a National Coverage Decision (NCD)from CMS and, following the initial approval of TAVI, released a critical consensus document offering a roadmap to responsible introduction of the new procedure.

Wells Fargo medical device analyst Larry Biegelsen (email), attending the STS/ACCF Transcatheter Heart Valve (THV) Symposium in Chicago last week, reports that uptake of the Edwards Sapien device has been slow, suggesting that the measured approach advocated by the ACC and STS and others has had an impact.

He cites three reasons for the slow uptake:
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