MINNEAPOLIS – 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.

In addition, Medtronic received FDA conditional approval to begin evaluating the CoreValve System in patients at intermediate risk for open-heart aortic valve replacement as part of the Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial. U.S. patient enrollment is expected to begin within weeks.

“With a sizeable population of Americans with severe aortic stenosis who have varying degrees of risk for open-heart aortic valve replacement surgery, the CoreValve U.S. Pivotal Trial and SURTAVI Trial are landmark trials that will provide critical insights about the appropriate use of the self-expanding CoreValve System,” said David H. Adams, M.D., chair of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center and national co-principal investigator of both the CoreValve U.S. Pivotal Trial and SURTAVI Trial. “We are optimistic and eager to fulfill the requirements of both trials with the goal of effectively demonstrating the value of CoreValve as an alternative to open-heart valve replacement surgery.”

Source: Medtronic, Inc.