Edwards Sapien M3 Transseptal TMVR System Approved by FDA

December 23, 2025—Edwards Lifesciences announced FDA approval for the company’s Sapien M3 transcatheter mitral valve replacement (TMVR) system as a transseptal therapy for the treatment of mitral regurgitation (MR).

According to the company, the Sapien M3 device 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 in patients who are deemed unsuitable for surgery or TEER by a multidisciplinary heart team.

The two-step Sapien M3 TMVR procedure involves delivery of a dock followed by delivery of a valve through a percutaneous, 29-F (outer diameter) steerable guide sheath inserted through the femoral vein, stated Edwards.

In April 2025, the Sapien M3 system received CE Mark approval.

In October 2025, 1-year data from the ENCIRCLE single-arm pivotal trial of the Sapien M3 for TMVR were reported by David Daniels, MD, et al at the TCT 2025 scientific symposium and published simultaneously by Mayra E. Guerrero, MD, et al in The Lancet (2025;406:2541-2550).

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, noted Edwards.