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Edwards’ Sapien M3 Mitral Valve Replacement Gets CE Mark
Edwards Lifesciences has secured the CE mark for its Sapien M3 transcatheter mitral valve replacement system, designed for patients with symptomatic mitral regurgitation who are ineligible for surgery or edge-to-edge therapy. The Sapien M3 is the first system to treat this condition using a transfemoral approach.
This CE approval allows Edwards to offer repair and replacement solutions for both mitral and tricuspid valves in the European Union. The company aims to expand its transcatheter mitral and tricuspid therapies (TMTT) to $2 billion in sales by 2030.
Edwards projects its TMTT sales will grow 50-60% in 2025, with current drivers like Pascal and Evoque valve devices. With FDA approval for Sapien M3 expected next year, Edwards is poised to build on this momentum, despite a slowdown in its TAVR business.
17-04-2025