Edwards Lifesciences today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. The company called it the world's first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR.
The procedure for the SAPIEN M3 system involves two steps, delivering the dock and then the valve to completely replace the mitral valve. The dock wraps around the native mitral leaflets which pulls them and the chordae inward toward the center of the dock, bringing the papillary muscles closer together. The dock creates a stable and consistent landing zone for placing the SAPIEN M3 valve. Both the dock and the valve are delivered through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.
Data have shown that the SAPIEN M3 system substantially reduces MR and improves quality of life. The company expects to present results from the ENCIRCLE pivotal trial, studying the SAPIEN M3 system, in late 2025. As part of Edwards’ commitment to building a body of real-world evidence, a European Post-Market Clinical Follow-up Study is planned to continue evaluation of the SAPIEN M3 system, with patients followed up to five years.
Edwards’ portfolio of transcatheter mitral and tricuspid therapies with CE Mark also includes the PASCAL Precision mitral and tricuspid valve repair system, and the EVOQUE tricuspid valve replacement system. The SAPIEN M3 system is not yet approved in the United States.
