Edwards SAPIEN M3 Mitral Valve Replacement System Gets CE Mark for Transcatheter Treatment

Apr 16, 2025

Edwards SAPIEN M3 Mitral Valve Replacement System Gets CE Mark for Transcatheter Treatment
Edwards SAPIEN M3 Mitral Valve Replacement System Gets CE Mark for Transcatheter Treatment

Source: Pharmabiz

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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.

FDA approval pending
heart innovation
minimally invasive surgery
cardiac care
FDA approval pending
heart innovation
minimally invasive surgery
cardiac care

Edwards SAPIEN M3 Mitral Valve Replacement System Gets CE Mark for Transcatheter Treatment

Apr 16, 2025

Edwards SAPIEN M3 Mitral Valve Replacement System Gets CE Mark for Transcatheter Treatment
Edwards SAPIEN M3 Mitral Valve Replacement System Gets CE Mark for Transcatheter Treatment

Source: Pharmabiz

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.

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FDA approval pending
heart innovation
minimally invasive surgery
cardiac care
FDA approval pending
heart innovation
minimally invasive surgery
cardiac care