FDA approves TMVR system from Edwards Lifesciences for high-risk heart patients
The U.S. Food and Drug Administration (FDA) has approved the Sapien M3 transcatheter mitral valve replacement (TMVR) sytem from Edwards Lifesciences for the treatment of mitral regurgitation (MR). The newly approved device was designed for patients with symptomatic moderate-to-severe or severe MR who may not be good candidates for mitral valve surgery or transcatheter edge-to-edge repair. The device is also indicated to treat high-risk patients who present with symptomatic mitral valve dysfunction linked to mitral annular calcification.
This is the first time the FDA has approved an interventional treatment for MR that is implanted using a transseptal approach.
The FDA’s decision was largely based on data from ENCIRCLE, a clinical trial of nearly 300 patients who underwent treatment from June 2020 to October 2023. The study’s one-year results were published in The Lancet in late 2025.[1]
“Over our more than 65-year history, Edwards has continued to push the boundaries of structural heart innovation, and today, with the addition of mitral replacement to our portfolio of FDA-approved transcatheter therapies that already includes mitral repair, we are expanding the treatable patient population in the U.S.,” Daveen Chopra, corporate vice president of transcatheter mitral and tricuspid therapies for Edwards Lifesciences, said in a statement. “Edwards is once again transforming care for patients with the Sapien M3 system, which is built on the foundation of the proven Sapien platform and is supported by positive one-year ENCIRCLE pivotal trial data.”
“Mitral regurgitation is very common among valvular heart diseases, and these patients often present with debilitating symptoms that are life-threatening and significantly diminish their quality-of-life,” added David Daniels, MD, an interventional cardiologist with Sutter West Bay Medical Group and structural heart section chief of Sutter’s Heart & Vascular Service Line. “Up to this point, many patients were unsuitable for available treatment options, leaving the vast majority untreated and suffering. The Sapien M3 system’s ability to provide a fully percutaneous mitral valve replacement that safely delivers near elimination of significant mitral regurgitation and meaningfully improves their symptoms is a game-changer for these patients.”
The Sapien M3 TMVR device gained CE mark approval back in April 2025.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.