Medical Device Network on MSN
Edwards receives FDA approval for mitral valve replacement system
Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve ...
The SAPIEN M3 system received CE Mark in April 2025, making it the world’s first approved transfemoral transcatheter mitral ...
(RTTNews) - Edwards Lifesciences Corp. (EW) on Tuesday said its SAPIEN M3 mitral valve replacement system received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral ...
IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach ...
Irvine, California Friday, December 26, 2025, 11:00 Hrs [IST] ...
Louisville, Ky.-based Norton Heart & Vascular Institute performed Kentucky’s first transcatheter tricuspid valve replacement using the Evoque system. The catheter-based procedure, developed by Edwards ...
Edwards Lifesciences EW announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making ...
IRVINE, California - Edwards Lifesciences (NYSE:EW) has received U.S. Food and Drug Administration approval for its SAPIEN M3 mitral valve replacement system, marking the first transcatheter therapy ...
An update from Venus Medtech (Hangzhou), Inc. Class H ( (HK:2500)) is now available. Venus Medtech (Hangzhou) Inc. has announced that it has formally submitted all application materials for EU CE MDR ...
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