Medtronic Nabs First Superiority Outcome In TAVR Versus Surgery
This article was originally published in The Gray Sheet
Data from Medtronic’s CoreValve High Risk Study provide the firm with significant momentum toward expanding the FDA label for its transcatheter aortic valve replacement device. Based on the results, FDA says no advisory panel will need to meet for the firm’s high-risk surgery submission. Observers say the jury is still out on CoreValve versus Sapien question.