After acquiring its developer last year, Edwards Lifesciences has now obtained a European approval for what it described as the world’s first transfemoral transcatheter mitral valve replacement implant.
Edwards bought Innovalve Bio Medical for about $300 million, in a deal announced last July. The Israeli startup’s two-piece Innostay system is designed to form a tight seal within the mitral valve despite the complexity of its natural shape.
The device—now part of Edwards’ Sapien M3 valve replacement—twists together and holds shut the heart’s tendon-like cords, to provide a secure base for the prosthetic implant. The system’s CE Mark covers patients with moderate to severe mitral regurgitation, the most common valvular heart disease, who are ineligible for open surgery or transcatheter edge-to-edge repair implants.
“Edwards’ 65-year legacy of structural heart innovation is firmly rooted in transforming care for underserved patient populations and the Sapien M3 system is built on the proven Sapien platform, which has been used in more than 8,000 procedures in the mitral position,” Edwards’ corporate VP for transcatheter mitral and tricuspid therapies, Daveen Chopra, said in a statement.
“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,” Chopra added.
The company said it plans to present results from a pivotal trial of Sapien M3 later this year. The implant is not yet approved in the U.S., but Edwards has targeted 2026 for a potential FDA green light.
Structural heart competitor Boston Scientific has also been eyeing startups in the mitral valve space; it recently led a $175 million funding round in 4C Medical, which is pursuing an international pivotal study for its globe-shaped AltaValve that fits entirely within the heart’s left atrium.