Edwards Lifesciences receives FDA approval for SAPIEN M3 mitral valve system

Edwards Lifesciences (EW) announced its SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive FDA approval for the treatment of mitral regurgitation. The system is indicated for patients deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy. The approval is based on one-year data from the ENCIRCLE pivotal trial, which showed significant mitral regurgitation elimination and improvements in symptoms.