Edwards receives CE mark for transfemoral mitral valve replacement system
Edwards Lifesciences has obtained European regulatory approval for its SAPIEN M3 system, making it the world’s first transcatheter mitral valve replacement therapy delivered via a transfemoral approach for treating mitral regurgitation.
Edwards Lifesciences Corporation has announced CE Mark approval for its SAPIEN M3 mitral valve replacement system, designed for patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy.
The SAPIEN M3 system represents a significant advancement in structural heart innovation as the world’s first approved transcatheter valve replacement therapy using a transfemoral approach specifically to treat mitral regurgitation.
Novel two-step procedure
The SAPIEN M3 system utilises a distinctive two-step procedure. Initially, a docking mechanism is delivered, followed by valve placement to completely replace the mitral valve. The dock envelops the native mitral leaflets, pulling them and the chordae inward towards the dock’s centre, which brings the papillary muscles closer together.
This innovative dock creates a stable and consistent landing zone for the SAPIEN M3 valve. Both components are delivered percutaneously through a 29F outer diameter steerable guide sheath inserted via the femoral vein.
“Mitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms,” said Dr. Michael Mullen, Barts Heart Centre, St Bartholomew’s Hospital, London, UK. “The SAPIEN M3 system establishes a new pathway for care with its novel docking mechanism and transseptal access, providing an important new treatment option for patients unsuitable for surgery or TEER.”
Building on established technology
The SAPIEN M3 system builds upon Edwards’ established SAPIEN platform, which has already been employed in over 8,000 procedures in the mitral position.
“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,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies.
Expanding treatment options
With this approval, Edwards Lifesciences now offers the only transcatheter portfolio in Europe that encompasses both replacement and repair treatment options for both mitral and tricuspid valves.
Clinical data has demonstrated that the SAPIEN M3 system substantially reduces MR and improves quality of life. The company plans to present results from its ENCIRCLE pivotal trial studying the system in late 2025, with a European Post-Market Clinical Follow-up Study planned to evaluate patients for up to five years.
The SAPIEN M3 system is not yet approved in the United States.
- For more information, visit: edwards.com
