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Edwards Lifesciences announced today that its Sapien M3 mitral valve replacement system received FDA approval for mitral ...

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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 ...

The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.