Edwards Lifesciences announced on April 14, 2025, that its SAPIEN M3 mitral valve replacement system received CE Mark approval for the transcatheter treatment of symptomatic mitral regurgitation (MR) patients. This approval is specifically for individuals deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy.
Leveraging the company’s proven SAPIEN technology, the SAPIEN M3 system is the world's first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR. This innovation positions Edwards as the only company offering a transcatheter portfolio that includes both replacement and repair options for both mitral and tricuspid valves in Europe.
The SAPIEN M3 system substantially reduces MR and improves quality of life for patients with limited treatment options. This CE Mark approval is expected to create a new treatment category in Europe, contributing meaningfully to Edwards' Transcatheter Mitral and Tricuspid Therapies (TMTT) segment from 2026.
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