FDA Approves First-of-Its-Kind SAPIEN M3 Mitral Valve Replacement System

Edwards Lifesciences has announced that its SAPIEN M3 mitral valve replacement system has become the first transcatheter therapy using a transseptal approach to receive approval from the U.S. Food and Drug Administration (FDA) for the treatment of mitral regurgitation (MR).

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is intended for patients with symptomatic moderate-to-severe or severe MR who are not suitable for surgery or transcatheter edge-to-edge repair (TEER). 

It is also indicated for patients with mitral valve dysfunction related to mitral annular calcification (MAC), including moderate-to-severe or severe MR, severe mitral stenosis (MS), or moderate MR with moderate MS, when other treatment options are unsuitable.

Mitral regurgitation is one of the most common valvular heart diseases, often causing severe symptoms and reducing quality of life. 

Many patients previously had no suitable treatment options. The SAPIEN M3 system offers a fully percutaneous replacement of the mitral valve, aiming to significantly reduce MR and improve patient outcomes.

The TMVR procedure is performed in two stages: first, a dock is delivered, followed by the valve, both through a steerable 29F guide sheath inserted via the femoral vein.

The SAPIEN M3 system received CE mark approval in April 2025, making it the first transfemoral transcatheter mitral valve replacement system approved worldwide. 

Edwards’ range of FDA-approved transcatheter therapies now includes mitral repair and replacement as well as the EVOQUE tricuspid valve replacement system.