The FDA has given the green light to Edwards Lifesciences to market its next-generation transcatheter aortic valve replacement (TAVR) device, the Sapien XT, for treatment in inoperable and high-risk patients with severe aortic stenosis.
The Sapien valve was the first TAVR device approved for use in the U.S. in 2011 for inoperable patients. In 2012, Edwards received the nod for its use in high-risk patients as well.
The next-generation valve and system were evaluated in the PARTNER II trial. Results presented at the American College of Cardiology scientific session in 2013 showed a lower rate of death and strokes at 30 days compared with the original Sapien valve. At 30 days, all-cause deaths were 3.5 percent for Sapien XT and 5.1 percent for the original device.
Both valves demonstrated better short-term outcomes than seen in PARTNER I, the pivotal trial for approval of Sapien.
The FDA’s approval of Sapien XT makes the 29mm valve size available for patients with large native annulus for TAVR using transfemoral and other access routes. Approval includes the NovaFlex+ transfemoral delivery system, which can use a 16-Fr expandable sheath, as well as the Ascendra+ transapical delivery systems.
Sapien XT received CE mark in Europe in 2010 and was approved in Japan in 2013.