Edwards Lifesciences (NYSE: EW) announced today that it received CE mark approval for its Sapien M3 mitral valve replacement system.
Sapien M3 treats patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR). Such patients are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. This makes Sapien M3 the first approved transcatheter valve replacement therapy using a transfemoral approach to treat MR.
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The procedure for Sapien M3 involves two steps. First, it requires the delivery of the dock and then the valve to completely replace the mitral valve. The nitinol dock wraps around the native mitral leaflets which pulls them and the chordae inward toward the center of the dock. This brings the papillary muscles closer together. The dock creates a stable and consistent landing zone for placing the SAPIEN M3 valve, which uses the same valve tissue and cobalt-chromium frame as the SAPIEN 3 valve.
Edwards said in a news release that delivery of both the dock and valve takes place through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.
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Irvine, California-based Edwards said data demonstrated substantially reduced MR and improved quality of life with Sapien M3. The company expects to present findings from the ENCIRCLE trial later this year. It also plans more post-market evaluation with follow-up out to five years.
Said Daveen Chopra, Edwards corporate VP, transcatheter mitral and tricuspid therapies:
“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.”
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