June 17th, 2014
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
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 21st, 2014
Harlan Krumholz presents a scenario based on the CoreValve trial and asks, “What do you say to your patient?”
April 15th, 2014
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 […]
April 7th, 2014
This week’s topics include SYMPLICITY HTN-3, CoreValve, MADIT-CRT, and more.
March 31st, 2014
E. Murat Tuzcu offers his perspective on the CHOICE trial comparing the CoreValve and Edwards Sapien XT devices for transcatheter aortic valve replacement.
March 30th, 2014
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
Interventionalist Ajay Kirtane offers his perspective on the new randomized trial comparing transcatheter (CoreValve) with surgical aortic valve replacement.
January 20th, 2014
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 29th, 2013
Key data on what will likely be the second transcatheter aortic valve to gain approval in the U.S. were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open […]