Edwards Lifesciences wins CE mark for transfemoral mitral valve replacement system

Edwards Lifesciences announced that its SAPIEN M3 mitral valve replacement system has received CE Mark approval, clearing the way for its use in Europe for patients with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who are not candidates for surgery or transcatheter edge-to-edge repair (TEER) therapy.

The SAPIEN M3 system is the first approved transcatheter mitral valve replacement therapy delivered via a transfemoral approach, offering a less invasive option for treating MR, the most common form of valvular heart disease.

“Edwards’ 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved patient populations,” said Daveen Chopra, corporate vice president of transcatheter mitral and tricuspid therapies at Edwards. “The SAPIEN M3 system is built on the proven SAPIEN platform, which has been used in more than 8,000 procedures in the mitral position.”

The procedure involves a two-step process: first delivering a docking mechanism that pulls the mitral valve leaflets and chordae inward, then placing the replacement valve into the newly created landing zone. Both components are delivered through a steerable guide sheath inserted via the femoral vein.

Michael Mullen of Barts Heart Centre in London called the approval a critical advance, stating: “The SAPIEN M3 system establishes a new pathway for care with its novel docking mechanism and transseptal access, providing an important new treatment option for patients unsuitable for surgery or TEER.”

Clinical data have shown that the device significantly reduces MR and improves patients' quality of life. Edwards plans to present results from the pivotal ENCIRCLE trial in late 2025 and will also conduct a European Post-Market Clinical Follow-up Study tracking outcomes for up to five years.

The SAPIEN M3 joins Edwards’ CE Mark-approved structural heart portfolio, which includes the PASCAL Precision mitral and tricuspid valve repair system and the EVOQUE tricuspid valve replacement system. The SAPIEN M3 is not yet approved for use in the United States.