FDAnews Device Daily Bulletin

CMS Updates TAVR Coverage, Adding CoreValve Trial Use

Sept. 4, 2012
Medicare will cover patients enrolled in Medtronic’s pivotal trial of the CoreValve system, under an Aug. 10 revision to the Centers for Medicare & Medicaid Services’ (CMS) coverage policy on transcatheter aortic valve replacement (TAVR). The coverage policy was originally released in May and covered only treatment with the Edwards Sapien TAVR system. While Sapien is FDA-approved for certain indications, CoreValve is still an investigational device in the U.S. CMS has not agreed to reimburse the trial costs of any other TAVR systems.
Devices & Diagnostics Letter