Edwards Lifesciences’ SAPIEN M3 Transcatheter Mitral Valve Replacement System. Credit: Edwards Lifesciences/Business Wire.

Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its SAPIEN M3 mitral valve replacement system.

It is said to be the first transcatheter therapy using a transseptal approach for mitral regurgitation (MR) to achieve this status.

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The approval applies to patients with symptomatic moderate-to-severe or severe MR who are not suitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, as determined by a multidisciplinary heart team.

Additionally, the SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is indicated for treating symptomatic mitral valve dysfunction, including cases of moderate MR with moderate MS, moderate-to-severe or severe MR, or severe mitral stenosis (MS), when associated with mitral annular calcification (MAC).

The TMVR procedure with SAPIEN M3 involves two main steps: first, delivery of the dock, then the valve, both via a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein. This replaces the mitral valve completely.

Edwards Lifesciences transcatheter mitral and tricuspid therapies corporate vice-president Daveen Chopra siad: “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 US.

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“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.”

The SAPIEN M3 system obtained CE Mark in April 2025.

The FDA-approved Edwards portfolio also includes the EVOQUE tricuspid valve replacement system and the PASCAL Precision mitral valve repair system.

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