US-based medical technology company Edwards Lifesciences has secured the CE mark for its Sapien M3 mitral valve replacement system to treat symptomatic mitral regurgitation (MR).
The Sapien M3 system is indicated for patients with MR, who are not suitable for surgery or transcatheter edge-to-edge repair (TEER) therapy.
It leverages Sapien technology and is the first approved transcatheter valve replacement therapy using a transfemoral approach for MR.
The Sapien M3 procedure involves a two-step process, including delivering the dock and then the valve to replace the mitral valve.
The dock encircles the native mitral leaflets, pulling them and the chordae inward, thus bringing the papillary muscles closer.
It creates a stable landing zone for the Sapien M3 valve, delivered through a 29F outer diameter steerable guide sheath via the femoral vein.
Edwards transcatheter mitral and tricuspid therapies corporate vice president Daveen Chopra said: “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.
“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.”
According to the clinical data, the Sapien M3 system significantly reduces MR and enhances patient quality of life.
A post-market clinical follow-up study in Europe is set to further evaluate the system, with patient monitoring extending up to five years.
In addition to the Sapien M3, Edwards received the CE mark for the Evoque tricuspid valve replacement system and the Pascal Precision mitral and tricuspid valve repair system.
St Bartholomew’s Hospital Barts Heart Centre Michael Mullen said: “Mitral regurgitation is the most common form of valvular heart disease and these patients suffer with debilitating and often life-threatening symptoms.
“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.”
