The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.
CLEVELAND – The list is out, and a dual-acting osteoporosis drug and a device for expanding the use of minimally invasive mitral valve surgery have come out on top.
TORONTO – Several U.S. and Canadian patients have recently undergone successful mitral valve surgery featuring a platform designed by Toronto-based Baylis Medical Inc. to provide more precise access to the wall separating the left and right sides of the heart. Robert Harrison, Baylis's director of research and development for cardiology, said in addition to locating the precise puncture point for mitral valve reconstruction, the Versacross transseptal solution has reduced the number of devices exchanged during the procedure to an all-in-one platform.
