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mitral regurgitation

PharmaDeviceNews mitral regurgitation
Mitria Medical's Subvalvular Spacer reaches U.S. patients under FDA expanded access at Cleveland Clinic
Medical Devices & Diagnostics

How Mitria Medical’s nitinol spacer challenges the edge-to-edge repair model for functional mitral regurgitation

Mitria Medical's Subvalvular Spacer reaches the U.S. under FDA compassionate use. What it means for FMR patients and what clinical evidence still needs to come.

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Edwards Lifesciences’ SAPIEN M3 is the first transseptal transcatheter mitral valve replacement system to receive U.S. Food and Drug Administration approval.
Medical Devices & Diagnostics

Edwards Lifesciences’ SAPIEN M3 FDA approval marks a turning point for transseptal mitral valve therapy

Edwards Lifesciences’ SAPIEN M3 becomes the first FDA-approved transseptal mitral valve replacement system. Explore how it reshapes TMVR in 2026.

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