Edwards Lifesciences has secured FDA approval for its SAPIEN M3 mitral valve replacement system, marking the first transcatheter therapy using a transseptal approach to treat mitral regurgitation (MR) in the United States. 

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER). It is also indicated for patients with mitral valve dysfunction associated with mitral annular calcification (MAC), including severe mitral stenosis or moderate MR combined with moderate MS, when other interventions are not viable. 

“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. Up to this point, many patients were unsuitable for available treatment options, leaving the vast majority untreated and suffering,” said David Daniels, cardiologist at Sutter West Bay Medical Group and structural heart section chief.  

“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 procedure is performed in two steps—dock delivery followed by valve delivery—through a 29F steerable guide sheath inserted via the femoral vein, completely replacing the mitral valve percutaneously. 

"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 US,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies.  

“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.”