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FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
IRVINE, Calif., December 23, 2025--Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is indicated for the treatment of symptomatic moderate-to-severe or severe MR in patients who are deemed unsuitable fo
About this update from Edwards Lifesciences Corporation
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