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FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

The SAPIEN M3 system, backed by a 299-patient trial, achieved 95.7% near elimination of mitral regurgitation in patients unsuitable for surgery or repair.

Summary by Rutland Herald
IRVINE, Calif.--(BUSINESS WIRE)--Dec 23, 2025-

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FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

IRVINE, Calif.--(BUSINESS WIRE)--Dec 23, 2025-

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medtechdive.com broke the news in on Tuesday, December 23, 2025.
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