Edwards wins FDA nod for Sapien M3 mitral valve, first transseptal transcatheter therapy

 Edwards Lifesciences (NYSE: EW)

 announced today that its Sapien M3 mitral valve replacement system received FDA approval for treating mitral regurgitation (MR).

The company said it marks the first approval for a transcatheter MR therapy utilizing a transseptal approach. It also comes ahead of the expected timeline for Edwards. The company previously earmarked early 2026 for approval as part of its recently outlined plan for growth. The device already carries CE mark, earning that 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. It’s 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 prove unsuitable for surgery or TEER therapy by a multidisciplinary heart team.

The Sapien M3 transfemoral transcatheter mitral valve replacement (TMVR) works in two steps. First, it utilizes a dock delivery, followed by valve delivery, completely replacing the mitral valve. Delivery of both takes place through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.

Edwards supported approval for the Sapien M3 with data from the ENCIRCLE study, which it presented at TCT in October. ENCIRCLE patients achieved low rates for death and low heart failure hospitalization for patients treated with the Sapien M3 TMVR system.

Patients who received the Sapien M3 valve therapy also achieved substantial mitral regurgitation (MR) elimination. They also demonstrated significant improvements in symptoms and quality of life.

https://www.massdevice.com/edwards-fda-approval-sapien-m3-tmvr