Edwards Lifesciences Corporation has received CE Mark approval for its SAPIEN M3 mitral valve replacement system, marking a significant advancement in treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are not suitable for surgery or transcatheter edge-to-edge repair (TEER). The approval positions Edwards as the first company to offer a transfemoral transcatheter mitral valve replacement solution.Key HighlightsWorld’s First Transfemoral Valve Replacement for MR

• SAPIEN M3 is the first approved transcatheter valve replacement for MR using a transfemoral approach.

• The system is built on Edwards' proven SAPIEN technology, with over 8,000 procedures already completed in the mitral position.

Dual-Component Procedure

• The system uses a two-step process: first placing a “dock” that anchors around native mitral leaflets, then delivering the valve.

• Both components are delivered via a 29F steerable guide sheath through the femoral vein, making the procedure less invasive.

Alternative for High-Risk Patients

• Designed specifically for patients who are unsuitable for surgery or TEER therapy.

• Offers a critical new treatment option for patients with debilitating, life-threatening MR symptoms.

Clinical and Quality of Life Impact

• Early data shows the SAPIEN M3 system significantly reduces mitral regurgitation and improves patient quality of life.

• ENCIRCLE pivotal trial results expected later in 2025.

• A European Post-Market Clinical Follow-up Study will track patient outcomes for up to 5 years.

Edwards’ Structural Heart Portfolio

• Edwards is now the only company offering both repair and replacement solutions for mitral and tricuspid valves in Europe.

• Its structural heart portfolio includes:

  1. PASCAL Precision mitral & tricuspid valve repair system

  2. EVOQUE tricuspid valve replacement system

  3. SAPIEN M3 mitral valve replacement system

Quotes from Leaders
Daveen Chopra, Corporate VP, Edwards Lifesciences:
“With the SAPIEN M3 approval, Edwards becomes the only company offering a full transcatheter solution for both mitral and tricuspid valve conditions in Europe.”Dr. Michael Mullen, Barts Heart Centre, London:
“This system provides a new pathway for MR patients with its innovative docking mechanism and less-invasive access. It’s a much-needed option for high-risk patients.”The CE Mark approval of the SAPIEN M3 system by Edwards Lifesciences marks a pivotal moment in minimally invasive cardiology, especially for patients previously left with no viable options for MR. With its unique design, transfemoral delivery, and dual-component system, the innovation sets a new standard in heart valve therapy and reflects Edwards’ commitment to enhancing patient care and longevity.