Transcatheter Mitral Valve Replacement System
Transcatheter Mitral Valve Replacement System
Source: Radiology Business
Date of Publication: April 15, 2025
Take-Home Messages:
1. CE Mark Approval:
• Edwards Lifesciences received CE mark approval for the Sapien M3 transcatheter mitral valve replacement (TMVR) system.
• Targeted for patients with symptomatic mitral regurgitation (MR) who are not suitable for surgery or TEER (transcatheter edge-to-edge repair).
2. Device & Procedure:
• The Sapien M3 system is delivered via transfemoral venous access using a steerable sheath.
• The procedure involves two steps:
• A dock is deployed that wraps around the native mitral leaflets.
• The Sapien M3 valve is then implanted within the dock, creating a secure landing zone.
3. Platform & Experience:
• The device is based on Edwards’ Sapien platform, which has been used in 8,000+ mitral procedures.
• Edwards is now the only company offering both replacement and repair options for mitral and tricuspid valves.
4. Clinical Importance:
• Mitral regurgitation is the most common valvular heart disease and often leads to debilitating symptoms.
• The Sapien M3 offers a new treatment pathway for patients unsuitable for existing therapies.
5. Future Outlook:
• Results from the ENCIRCLE pivotal trial (evaluating safety and effectiveness) expected in late 2025.
• The system is not yet approved by the U.S. FDA.