In recent news, Edwards Lifesciences has gone on to win the FDA approval for its Sapien M3 mitral valve replacement system so as to treat mitral regurgitation – MR.
The company said that it is the first approval for a transcatheter MR therapy that makes use of a transseptal approach.
Interestingly, the approval came earlier than Edwards anticipated. The company in the past had earmarked early 2026 for approval as part of the recently outlined plan for its growth. Apparently. The device went on to earn a CE mark in April 2025.
The Sapien M3 mitral valve replacement system got the approval so as to treat the symptomatic moderate-to-severe or severe MR in patients. Such patients are regarded to be unsuitable for surgery or transcatheter edge-to-edge – TEER therapy. The system is also indicated so as to treat symptomatic mitral valve dysfunction, which is moderate-to-severe or severe MR, severe mitral stenosis – MS, or even moderate MR with moderate MS, which is associated with mitral annular calcification – MAC. Again, those patients are not suitable for surgery or TEER therapy by a multidisciplinary heart team.
It is well to be noted that the Sapien M3 transfemoral transcatheter mitral valve replacement – TMVR goes on to work in two steps. First, it makes use of a nitinol dock delivery, which is then followed by valve delivery, thereby completely replacing the mitral valve. The roll out of both takes place via a percutaneous, which is a 29F outer diameter steerable guide sheath that is inserted by way of the femoral vein.
Edwards went on to support the approval for the Sapien M3 along with data from the ENCIRCLE study, which it went on to present at TCT in October 2025. ENCIRCLE patients attained low rates for death as well as low heart failure hospitalization in terms of patients that were treated with the Sapien M3 TMVR system.
Patients who availed the Sapien M3 valve therapy also attained substantial mitral regurgitation – MR elimination. They also showcased quite significant enhancements in symptoms as well as quality of life.
According to the corporate VP for transcatheter mitral and tricuspid therapies at Edwards, Daveen Chopra, in their more than 65-year history, Edwards has consistently pushed the boundaries when it comes to structural heart innovation, and now with the addition of mitral replacement to their existing portfolio of FDA-approved transcatheter therapies, which already includes mitral repair, they are indeed expanding the treatable patient population in the U.S. Chopra further said that Edwards is once again going ahead and transforming care for patients because of the Sapien M3 system, which apparently is built on the foundation of the proven Sapien platform and is supported because of positive one-year ENCIRCLE pivotal trial data.
