Medtronic announces FDA approval for revised TAVR labeling, begins study
Medtronic announced that the U.S. Food and Drug Administration has approved an investigational device exemption, or IDE, to initiate a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. Medtronic separately received FDA approval for revised commercial labeling for the CoreValve Evolut TAVR system that removed a precaution for the treatment of bicuspid severe aortic stenosis patients deemed at intermediate or greater risk for surgical aortic valve replacement. "As a leader in heart valve solutions, this label revision enables us to provide proactive training and education on procedural TAVR sizing and placement in this patient population. The bicuspid study, in addition to new studies on TAVR efficiencies and leaflet mobility, will provide important insights as we look to further refine TAVR therapy," said Pieter Kappetein, M.D., vice president, medical affairs for Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic.