Edwards Lifesciences announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making it the first transseptal transcatheter therapy approved in the U.S. for treating mitral regurgitation in patients unsuitable for surgery or TEER. Approval was supported by one-year ENCIRCLE trial data showing 95.7% effective MR reduction and significant symptom improvement.

Source: Edwards Lifesciences via Business Wire, December 23, 2025.