Label expansion for CoreValve System

|By:, SA News Editor

The FDA approves Medtronic's (MDT -0.6%) transcatheter aortic valve replacement (TAVR) CoreValve System for patients at high risk for open-heart surgery. Its original indication, approved in January 2014, is for patients at extreme risk for open-heart surgery. The basis for the expanded label was a Phase 3 clinical trial comparing TAVR using CoreValve to traditional surgical aortic valve replacement. One-year survival in patients receiving the CoreValve System was 85.8% vs 80.9% for patients receiving the traditional procedure. The results were statistically significant.

The Medtronic device competes directly with Edwards Lifesciences' (EW -3.1%) Sapien TAVR system. Last month, MDT agreed to pay EW $750M plus royalties to settle patent infringement claims.