FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System

Edwards Lifesciences Corporation has received FDA approval for its SAPIEN M3 mitral valve replacement system, marking the first transcatheter therapy using a transseptal approach approved in the U.S. for treating symptomatic moderate-to-severe mitral regurgitation in patients unsuitable for surgery or TEER therapy. This approval expands Edwards Lifesciences’ portfolio of FDA-approved transcatheter mitral and tricuspid therapies.