Edwards gains FDA approval for Sapien M3 mitral valve replacement system

Edwards has announced FDA approval for its Sapien M3 mitral valve replacement system, intended for patients with moderate to severe mitral regurgitation who are not candidates for surgery or transcatheter edge-to-edge repair. Mitral regurgitation occurs when the valve between the heart’s left chambers does not close completely, causing blood to flow backward.

The Sapien M3 is the first FDA-approved transcatheter therapy for mitral regurgitation using a transseptal approach. The procedure involves placing a docking system followed by the valve to fully replace the mitral valve.

Approval was supported by a 299-patient pivotal trial, showing significant reduction of regurgitation and meaningful improvements in symptoms and quality of life, as reported in The Lancet. Edwards highlighted that the device provides a treatment option for patients previously ineligible, and it has also received CE mark approval in Europe.

29-12-2025