Edwards receives CE mark for Sapien M3 mitral valve replacement device

Edwards Lifesciences has earned CE mark clearance for its Sapien M3 device, a transfemoral transcatheter mitral valve replacement (TMVR) system intended for patients with symptomatic mitral regurgitation who are not candidates for surgery or edge-to-edge repair therapies. The approval allows Edwards to expand its transcatheter mitral and tricuspid therapies (TMTT) portfolio in Europe, where it already markets Pascal and Evoque repair and replacement systems. With Sapien M3, Edwards becomes the first company to offer a TMVR device using a transfemoral approach, a less invasive option for high-risk patients. The company plans to seek FDA approval for Sapien M3 in the U.S. in 2026 as part of its strategy to grow TMTT sales to $2 billion by 2030.

While mitral repair systems like Abbott’s Mitraclip and Edwards’ Pascal currently dominate the market, Edwards sees strong potential for replacement options in patients who aren’t well-suited for repair. Company leadership and analysts agree that repair will remain the first-line option in the near term, but replacement devices such as Sapien M3 are positioned as complementary alternatives that can expand treatment options. Edwards’ aggressive TMTT expansion comes as growth slows in its core transcatheter aortic valve replacement (TAVR) business. With high expectations for its mitral and tricuspid offerings, Edwards aims to report increased momentum throughout 2025, supported by strong demand for Evoque and anticipated uptake of Sapien M3.