The FDA has approved Edwards Lifesciences Corp.’s Sapien M3 transcatheter mitral valve replacement system.
The U.S. approval, announced last week, comes eight months after the device received CE Mark approval for use in Europe, making it the world’s first approved transcatheter valve replacement therapy using a transfemoral approach to treat mitral regurgitation, according to the company.
“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,” Daveen Chopra, corporate vice president for transcatheter mitral and tricuspid therapies, said in a statement.
Shares in Edward were little changed today at $86.86 per share and a $51 billion market cap (NYSE: EW).
