Transcatheter Mitral Valve Replacement System Receives FDA Clearance

Dec. 26, 2025 — Edwards Lifesciences has announced the company’s SAPIEN M3 mitral valve replacement system, a transcatheter therapy using a transseptal approach, has received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR).

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is indicated for the treatment of symptomatic moderate-to-severe or severe MR in patients who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy by a multidisciplinary heart team. It is also indicated for the treatment of symptomatic mitral valve dysfunction (moderate-to-severe or severe MR, severe mitral stenosis (MS), or moderate MR with moderate MS) associated with mitral annular calcification (MAC) in patients who are deemed unsuitable for surgery or TEER therapy by a multidisciplinary heart team.

“Mitral regurgitation is very common among valvular heart diseases, and these patients often present with debilitating symptoms that are life-threatening and significantly diminish their quality-of-life. Up to this point, many patients were unsuitable for available treatment options, leaving the vast majority untreated and suffering,” said David Daniels, M.D., Sutter West Bay Medical Group cardiologist and structural heart section chief of Sutter’s Heart & Vascular Service Line. “The SAPIEN M3 system’s ability to provide a fully percutaneous mitral valve replacement that safely delivers near elimination of significant mitral regurgitation and meaningfully improves their symptoms is a game-changer for these patients.”

The SAPIEN M3 TMVR procedure involves two steps: dock delivery followed by valve delivery, completely replacing the mitral valve. Both the dock and the valve are delivered through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.

One-year data from the ENCIRCLE single-arm pivotal trial was presented at TCT on October 27, 2025, and was simultaneously published in The Lancet. The trial achieved all primary and secondary endpoints for safety and effectiveness in the trial’s main cohort (299 patients unsuitable for other treatment options), achieving significant MR elimination (95.7% MR ≤ 0/1+) and meaningful improvements in symptoms and quality-of-life.

"Over our more than 65-year history, Edwards has continued to push the boundaries of structural heart innovation, and today, with the addition of mitral replacement to our portfolio of FDA-approved transcatheter therapies that already includes mitral repair, we are expanding the treatable patient population in the US,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “Edwards is once again transforming care for patients with the SAPIEN M3 system, which is built on the foundation of the proven SAPIEN platform and is supported by positive one-year ENCIRCLE pivotal trial data.”

The SAPIEN M3 system received CE Mark in April 2025. Edwards’ portfolio of FDA-approved transcatheter mitral and tricuspid therapies includes the PASCAL Precision mitral valve repair system and the EVOQUE tricuspid valve replacement system.