Edwards Lifesciences Corp. today announced that it received CE Mark approval, the European equivalent of the Food and Drug Administration, for its Sapien M3 mitral replacement system.
The device replaces the mitral valve in patients with severe mitral regurgitation (MR). It’s said to be the world’s first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR, according to the company.
“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,” said Daveen Chopra, corporate vice president of transcatheter mitral and tricuspid therapies at Edwards.
Edwards last year said it anticipates FDA approval in 2026.
