Medtronic Gets FDA Approval to Study Risk Patients in Surtavi

Medtronic, Inc.

has reached two clinical program milestones for its CoreValve® System in the United States. First, it completed enrollment in its study of high risk patients in its CoreValve®U.S. Pivotal Trial, which concludes the total Trial enrollment of more than 1,500 patients with severe aortic stenosis who are at high or extreme risk for aortic valve surgery. Medtronic continues to enroll extreme risk patients in the Trial as part of the U.S. Food and Drug Administration (FDA) Continued Access Policy and is seeking approval to continue enrolling high risk patients under this policy.