Edwards Lifesciences' SAPIEN M3 Receives CE Mark, Becomes First Transfemoral Mitral Valve Replacement System

Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system has received CE Mark, making it the first transcatheter mitral valve replacement (TMVR) system approved for transfemoral access in Europe. This approval allows use in patients with symptomatic moderate-to-severe or severe mitral regurgitation who are not suitable candidates for surgery or TEER therapy.

The SAPIEN M3 system, based on Edwards’ proven SAPIEN valve platform, consists of a two-step procedure using a novel docking mechanism followed by valve deployment. Delivered through a femoral vein approach, the system minimizes invasiveness and creates a consistent landing zone for the valve.

Clinical data show that the system significantly reduces mitral regurgitation and improves patients’ quality of life. Edwards plans to present results from the ENCIRCLE pivotal trial later in 2025 and conduct a five-year post-market clinical study in Europe.

With this approval, Edwards becomes the only company in Europe offering both transcatheter repair and replacement options for both mitral and tricuspid valves. The SAPIEN M3 system is not yet approved in the United States.