In December 2025, the U.S. Food and Drug Administration approved the Edwards SAPIEN M3 Transcatheter Mitral Valve Replacement (TMVR) System, marking the first time a transseptal transcatheter approach for treating mitral regurgitation has received FDA clearance. For the structural heart team at OCHI and Providence St. Joseph Hospital, this is the kind of development that opens real doors for patients who had nowhere left to turn.
What Is the SAPIEN M3?
The SAPIEN M3 is built on Edwards Lifesciences’ well-established SAPIEN platform, the same technology underlying thousands of successful aortic valve procedures. It has been redesigned specifically to treat the mitral valve. The device is indicated for patients with symptomatic moderate-to-severe or severe mitral regurgitation who are not suitable candidates for open-heart surgery or transcatheter edge-to-edge repair (TEER). It is also approved for patients with mitral annular calcification (MAC), a condition that has historically excluded many patients from available treatments.
How the Procedure Works
The SAPIEN M3 procedure is done in two steps:
- Dock delivery: a nitinol docking frame is placed at the mitral valve to create a stable landing zone
- Valve delivery: the replacement valve is deployed within the dock, fully replacing the native mitral valve.
Both steps are completed through a small puncture in the femoral vein in the leg. No open-heart surgery, no chest incisions. The delivery system crosses the wall between the heart’s right and left chambers to reach the mitral valve from above.
What the Clinical Data Shows
One-year results from the ENCIRCLE pivotal trial, presented at TCT 2025 and published simultaneously in The Lancet, found that 95% of patients had near-complete elimination of mitral regurgitation at one year. Mortality and heart failure hospitalization rates came in well below the prespecified benchmark, even among a high-risk patient population with an average age of 75.
Our Program at St. Joseph Hospital
Dr. Kolski directs the Stanley W. Ekstrom Valve Center at Providence St. Joseph Hospital, the busiest catheter-based heart valve program in Orange County, with outcomes ranked in the top 10% nationally for length of stay and complications. He and his team have performed over 100 MitraClip procedures and are experienced across the full spectrum of transcatheter mitral therapies. The SAPIEN M3 approval is the kind of advance this program has been built to deliver for patients in Orange County who previously had no surgical or repair options available to them.
If you or a family member has been diagnosed with mitral regurgitation and told that surgery or repair is not an option, we encourage you to schedule a consultation.
Learn more: Edwards Lifesciences SAPIEN M3 Overview