The company said it’s the first approval for a transcatheter MR therapy utilizing a transseptal approach.

The approval came earlier than Edwards expected. The company previously earmarked early 2026 for approval as part of its recently outlined plan for growth. The device earned a CE mark in April.

Sapien M3 received approval for treating symptomatic moderate-to-severe or severe MR in patients. Such patients are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. The system is also indicated for treating 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). Again, those patients are unsuitable for surgery or TEER therapy by a multidisciplinary heart team.