Edwards Lifesciences announced today that its Sapien M3 mitral valve replacement system received FDA approval for mitral ...
The Sapien M3 transcatheter mitral valve replacement system won FDA approval -- making it the first on the market to utilize ...
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EW wins FDA approval for SAPIEN M3 as first transseptal TMVR therapy
Edwards Lifesciences EW announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making ...
The US Food and Drug Administration has approved the Sapien M3 system for transseptal transcatheter mitral valve replacement (TMVR) for use in patients with symptomatic moderate-to-severe mitral ...
Edwards Lifesciences (EW) announced on Tuesday that the U.S. Food and Drug Administration approved its SAPIEN M3 ...
The SAPIEN M3 system received CE Mark in April 2025, making it the world’s first approved transfemoral transcatheter mitral ...
First-of-its-kind Edwards SAPIEN M3 transcatheter mitral valve system secures FDA approval for transseptal mitral ...
Transcatheter heart valve repair and replacement have reshaped how structural heart disease is treated, and the market is ...
SAN FRANCISCO -- For selected patients with mitral regurgitation (MR), the Sapien M3 device delivered highly promising 1-year outcomes for the desperate field of transcatheter mitral valve replacement ...
IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced it has exercised its option to acquire Innovalve Bio Medical Ltd., an early-stage transcatheter mitral valve ...
Edwards Lifesciences Corporation EW announced its decision to acquire Innovalve Bio Medical Ltd., an early-stage transcatheter mitral valve replacement (TMVR) company. This follows Edwards Lifescience ...
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