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Edwards Lifesciences Secures CE Mark for Sapien M3 Mitral Valve Replacement System
Edwards Lifesciences has received the CE mark for its Sapien M3 transcatheter mitral valve replacement system, marking a significant milestone in its transcatheter mitral and tricuspid therapies (TMTT) strategy. The system, designed for patients with symptomatic mitral regurgitation who are not suitable for surgery or edge-to-edge repair, is the first globally to use a transfemoral approach for this condition.
The approval enables Edwards to offer a full portfolio in the EU for mitral and tricuspid valve repair and replacement, joining its Pascal and Evoque systems. Sapien M3 now enters a competitive European market already served by Abbott’s MitraClip and Edwards’ own Pascal repair device.
Edwards is aiming for FDA approval of Sapien M3 by 2025 and expects its TMTT portfolio to grow significantly, with projected sales reaching $2 billion by 2030.
23-04-2025