Edwards' SAPIEN M3 Received CE Mark as the World’s First Transfemoral TMVR System
On April 14, 2025, Edwards Lifesciences Corporation announced that its SAPIEN M3 mitral valve replacement system had received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who were considered unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy. Building on the company’s established SAPIEN technology, the SAPIEN M3 became the world’s first approved transcatheter valve replacement therapy to utilize a transfemoral approach for treating MR.
“Edwards’ 65-year legacy of structura...
