Edwards Lifesciences has received approval from the U.S. Food and Drug Administration for its SAPIEN M3 transcatheter mitral valve replacement system, making it the first therapy using a fully percutaneous transseptal approach cleared in the United States for the treatment of mitral regurgitation.
Edwards Lifesciences is a global leader in structural heart innovation, focused on improving patient lives through breakthrough technologies, evidence-based solutions, and partnerships with clinicians and healthcare stakeholders. The company operates with a patient-focused culture to deliver life-changing therapies to those in need.
The system is indicated for patients with symptomatic moderate-to-severe or severe mitral regurgitation who are deemed unsuitable for surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team. It is also approved for the treatment of symptomatic mitral valve dysfunction, including moderate-to-severe or severe mitral regurgitation, severe mitral stenosis, or moderate mitral regurgitation with moderate stenosis, associated with mitral annular calcification in patients unsuitable for surgery or edge-to-edge repair.
The SAPIEN M3 procedure involves a two-step process with a docking mechanism followed by valve deployment, delivered through a 29F steerable guide sheath inserted via the femoral vein, fully replacing the mitral valve without open-heart surgery.
Approval was supported by one-year results from the ENCIRCLE pivotal trial, a single-arm study involving 299 patients considered unsuitable for existing therapies. The trial met all primary and secondary endpoints for safety and effectiveness, achieving significant mitral regurgitation elimination in 95.7 percent of patients and meaningful improvements in symptoms and quality of life. The results were presented at the Transcatheter Cardiovascular Therapeutics conference and published in The Lancet.
Earlier in 2025, the SAPIEN M3 received CE Mark approval in Europe, becoming the world’s first approved transfemoral transcatheter mitral valve replacement system. The FDA clearance expands Edwards’ portfolio of transcatheter mitral and tricuspid therapies, which includes the PASCAL Precision mitral valve repair system and the EVOQUE tricuspid valve replacement system.
Also Read