Edwards Lifesciences announces key approval for new mitral valve replacement system
Edwards Lifesciences has received CE mark approval for its Sapien M3 transcatheter mitral valve replacement system for patients with symptomatic mitral regurgitation who are not suitable candidates for surgery or transcatheter edge-to-edge repair (TEER).
The Sapien M3 implant procedure involves delivering the system’s dock and then its valve through the patient’s femoral vein with a steerable guide sheath. The dock wraps around the native mitral leaflets, creating a landing zone for the Sapien M3 valve.
“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,” Daveen Chopra, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, said in a statement. “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.”
“Mitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms,” added Dr. Michael Mullen, an interventional cardiologist with Barts Heart Centre at St. Bartholomew’s Hospital in London, and colleagues. “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 plans on sharing results from the ENCIRCLE pivotal trial, designed to evaluate the Sapien M3 system’s safety and effectiveness, in late 2025. Additional research is also on the horizon, including a post-market follow-up study focused on data from patients in Europe.
The Sapien M3 system has not yet been approved by the U.S. Food and Drug Administration.
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