FDA Approves Sapien M3 for Transseptal Mitral Valve Replacement

The US Food and Drug Administration has approved the Sapien M3 system for transseptal transcatheter mitral valve replacement (TMVR) for use in patients with symptomatic moderate-to-severe mitral regurgitation (MR) who are ineligible for surgery or transcatheter edge-to-edge repair (TEER), according to a Tuesday announcement from device maker Edwards Lifesciences. 

It is also approved for the treatment of symptomatic mitral valve dysfunction associated with mitral annular calcification (MAC) in patients unsuitable for surgery or TEER as assessed by a multidisciplinary heart team.

The FDA decision marks the first approval of a TMVR device that is delivered by a fully percutaneous transseptal approach.

In the US, TMVR with Tendyne (Abbott) was approved earlier this year for patients with moderate-to-severe MR, severe mitral stenosis, or moderate MR with moderate-or-greater mitral stenosis caused by MAC who are deemed unsuitable for surgery and have anatomy that is unfavorable for TEER. Tendyne, though, is delivered via a transapical approach.  

The nod for Sapien M3 from US regulators is based on 1-year results from the single-arm ENCIRCLE trial, which was presented at TCT 2025 and published in the Lancet.

Among 299 patients (median age 77 years; 49% female), most with secondary MR, the rate of all-cause death or hospitalization for heart failure was 25.2%, which was significantly lower than the performance goal set at the start of the study. Most patients had an improvement in NYHA functional class, quality of life, and 6-minute walk distance, in addition to a significant elimination of MR.  

Sapien M3 previously received CE Mark approval in Europe in April 2025.