Edwards Lifesciences has secured CE mark approval for its Sapien M3, the world’s first transfemoral transcatheter mitral valve replacement (TMVR) system. This marks a major advance for patients with moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or TEER (transcatheter edge-to-edge repair).
A Two-Step Breakthrough Procedure
Sapien M3’s approach involves:
Step 1: A specially designed dock is deployed to encircle the native mitral leaflets and pull them inward, creating a stable landing zone.
Step 2: The valve is then implanted within the dock for complete replacement.
Both components are delivered percutaneously through the femoral vein using a 29F steerable sheath, eliminating the need for open-heart surgery.
Early Outcomes Show Promise
Initial data from Edwards suggests:
Significant MR reduction
Improved patient quality of life
Further results are expected from the ENCIRCLE trial later this year, with five-year post-market follow-up planned.
Sapien M3 represents a pivotal innovation in structural heart therapy, potentially redefining care for high-risk mitral patients across Europe.
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