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2 News Found

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement
Medical Device | December 27, 2025

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR


USFDA approves Edwards Mitris Resilia valve
Medical Device | March 31, 2022

USFDA approves Edwards Mitris Resilia valve

The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve


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