Edwards receives CE mark for Sapien M3 mitral valve replacement device

Edwards receives CE mark for Sapien M3 mitral valve replacement device

The replacement system is launching into markets already served by repair devices, namely Edwards’ Pascal and Abbott’s Mitraclip.

Edwards’ Sapien M3 Gains European Approval - Orange County Business Journal

Edwards Lifesciences Corp. today announced that it received CE Mark approval, the European equivalent of the Food and Drug Administration, for its Sapien M3 mitral replacement system. The device replaces the mitral valve in patients with severe mitral regurgitation (MR). It’s said to be the world’s first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR, according to the company. “We were the first to gai…

Edwards’ Sapien M3 Transfemoral TMVR System Receives CE Mark Approval - Cardiac Interventions Today

April 14, 2025—Edwards Lifesciences Corporation announced that the company’s Sapien M3 transcatheter mitral valve replacement (TMVR) system received CE Mark approval for the transfemoral treatment of patients with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. According to Edwards, data have shown that the Sapien M3 TMVR system substantially r…

Edward Lifesciences’ Sapien M3 transfemoral mitral valve system gains CE mark - Cardiovascular News

Sapien M3 Edwards Lifesciences has announced that the company’s Sapien M3 mitral valve replacement system has received CE mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company’s Sapien technology, the Sapien M3 system is the world’s first approved transcatheter valve repla…