Posts Tagged ‘Sapien’

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June 17th, 2014

FDA Approves Second-Generation Heart Valve from Edwards Lifesciences

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). The Sapien XT is the successor to the first-generation Sapien device, which […]


May 21st, 2014

Medtronic and Edwards Lifesciences Resolve Patent Disputes

After years of protracted and often bitter litigation in the U.S. and abroad, Edwards Lifesciences and Medtronic today announced a broad resolution to all their patent disputes over transcatheter heart valves. Medtronic will pay more than a billion dollars over the course of the agreement, which lasts until April 2022. Edwards will first receive a one-time payment of $750 million, followed […]


April 15th, 2014

CoreValve Availability In U.S. Threatened By Court Decision

A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery. The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered the […]


March 30th, 2014

First TAVR Comparison Trial Favors Sapien XT Over CoreValve

With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards […]


March 29th, 2014

TAVR: Are You Impressed Now?

Interventionalist Ajay Kirtane offers his perspective on the new randomized trial comparing transcatheter (CoreValve) with surgical aortic valve replacement.


January 20th, 2014

FDA Grants Earlier Than Expected Approval for Medtronic’s CoreValve

The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. The approval was based largely on results from the Extreme Risk Study of the CoreValve […]


October 24th, 2012

TCT: Impressive Survival Benefit for TAVR in Inoperable Patients at 3 Years

At the TCT meeting in Miami, Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At 3 years, the mortality advantage continued to grow for TAVR over standard therapy. All-cause mortality at 3 years: 80.9% […]


October 22nd, 2012

FDA Approves the Sapien Transcatheter Heart Valve for High-Risk Patients

The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but are at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were […]


July 16th, 2012

The Name Game: Why Did “TAVI” Suddenly Become “TAVR”?

One of the great, unexplained mysteries of the cardiology world in recent years is the sudden name change from TAVI  (transcatheter aortic valve implantation), which had been the universally-used name for the procedure during most of its development period, to TAVR  (transcatheter aortic valve replacement) about the time when the procedure edged closer to U.S. approval. Now, in […]


June 14th, 2012

FDA Advisory Panel Recommends Expanded Indication for Sapien Transcatheter Heart Valve

The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device was […]