Edwards’ Sapien M3 Transfemoral TMVR System Receives CE Mark Approval

April 14, 2025—Edwards Lifesciences Corporation announced that the company’s Sapien M3 transcatheter mitral valve replacement (TMVR) system received CE Mark approval for the transfemoral treatment of patients with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy.

According to Edwards, data have shown that the Sapien M3 TMVR system substantially reduces MR and improves quality of life. The company expects to present results from the ENCIRCLE pivotal trial of the Sapien M3 system in late 2025. Additionally, the company is planning a European postmarket clinical follow-up study to continue evaluation of the device with follow-up to 5 years.

As noted in the press release, the procedure for the Sapien M3 system involves delivering a dock and then the valve through a percutaneous 29-F (outer diameter) steerable guide sheath. The dock creates a stable and consistent landing zone for placing the Sapien M3 valve.

“MR is the most common form of valvular heart disease, and these patients suffer with debilitating and often life-threatening symptoms,” commented Michael Mullen, MD, in Edwards’ press release. Dr. Mullen, who is with Barts Heart Centre, St Bartholomew’s Hospital in London, United Kingdom, continued, “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.”

The Sapien M3 system is not yet approved in the United States, advised Edwards Lifesciences.