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.
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You can also learn more about the transcatheter heart valve market in our Medtech Market Report on the space. Purchase it here.
The Sapien M3 transfemoral transcatheter mitral valve replacement (TMVR) works in two steps. First, it utilizes a nitinol 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.
“Over our more than 65-year history, Edwards has continued to push the boundaries of structural heart innovation, and today, with the addition of mitral replacement to our portfolio of FDA-approved transcatheter therapies that already includes mitral repair, we are expanding the treatable patient population in the U.S.,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “Edwards is once again transforming care for patients with the Sapien M3 system, which is built on the foundation of the proven Sapien platform and is supported by positive one-year ENCIRCLE pivotal trial data.”
Medical Design & Outsourcing: Learn more about the Sapien M3 system from the team that developed it in our free 72-page Min-Vasive Medtech special report
