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 offered the first nonsurgical approach to aortic valve replacement. A competing device, Medtronic’s CoreValve, was approved earlier this year and has gained considerable interest. The Sapien XT is expected to be more competitive, in part because of its lower profile and the availability of a 29-mm valve size for patients with a larger native annulus.
Edwards said the Sapien XT will be immediately available along with its accompanying transfemoral, transapical, and transaortic delivery systems.
“There is a substantial and growing body of evidence that the SAPIEN XT valve benefits both high-risk and inoperable patients, and clinicians have documented these consistently positive results in both randomized studies and European country registries,” said Martin Leon, the co-principal investigator for the PARTNER II Trial, which evaluated the SAPIEN XT valve, in a press release. “The results from the PARTNER II Trial in treating U.S. inoperable patients with the SAPIEN XT valve demonstrated a reduction in complications with the TAVR procedure, and improved patient outcomes over earlier trials.”