The first-in-human study of Edwards' Sapien M3 transseptal transcatheter mitral valve replacement device shows it is a feasible option for patients with severe mitral regurgitation who would be at high risk during open mitral-valve surgery. John Webb of St. Paul's Hospital in Vancouver presented the results of the first 10 cases with Sapien M3 during a late-breaking trial-session at the CRT meeting on March 5.
Sapien M3 is a combination of Edwards' successful 29 mm Sapien 3 transcatheter aortic valve and a unique nitinol docking device that adapts it for the mitral valve. The valve is compatible with a 20f eSheath delivery device and has a knitted polyethylene terephthalate skirt to create a seal between the native leaflets and the dock
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