Edwards Lifesciences has earned CE mark approval for its Sapien M3 mitral valve replacement system for transcatheter treatment of patients with symptomatic (moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy.

With this approval, Sapien M3 is now the first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR.

Procedures with Sapien M3 involve two steps, delivering the dock then the valve to completely replace the mitral valve. The dock wraps around native mitral leaflets to pull them and the chordae inward toward the center of the dock, bringing the papillary muscles closer together.

The dock creates a stable, consistent landing zone to place the Sapien M3 valve. Both dock and valve are delivered through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.

Edwards said data has shown Sapien M3 substantially reduces MR and improves quality of life. The company plans to present results from its ENCIRCLE pivotal trial studying Sapien M3 in late 2025. A European post-market clinical follow-up study is expected to continue evaluation, with patients followed up to five years.

“Mitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms,” said Dr. Michael Mullen, Barts Heart Centre, St Bartholomew’s Hospital, London, UK. “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.”

“Edwards’ 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved patient populations and 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,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “We were the first to gain CE Mark for a transcatheter tricuspid valve replacement system, and with the SAPIEN M3 system’s approval, Edwards is now the only company providing a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves, meeting the broad and diverse needs of these patients in Europe.”