Edwards Lifesciences: SAPIEN XT Valve Meets Primary Endpoint In PARTNER II Trial

(RTTNews) - Edwards Lifesciences Corp. (EW) announced that the randomized PARTNER II Trial comparing the SAPIEN XT valve to surgery in intermediate-risk patients successfully achieved its primary endpoint at two years. The PARTNER II Trial randomized 2,032 patients at 57 centers in the U.S. and Canada between December 2011 and November 2013. The composite primary endpoint of the trial was all-cause mortality or disabling stroke at two years. The event rate was 19.3 percent for transcatheter aortic valve replacement with the SAPIEN XT valve, which was non-inferior, compared with 21.1 percent for surgery. For the 76 percent of SAPIEN XT patients receiving the transfemoral approach, the as-treated event rate was 16.3 percent, which was superior to surgery.

The SAPIEN XT valve and, the SAPIEN 3 valve, are approved in U.S. for the treatment of high-risk patients with severe, symptomatic aortic stenosis; the valves are not approved for the treatment of intermediate-risk patients.