Medtronic Reaches Milestones in Studies of CoreValve System

August 29, 2012—Medtronic, Inc. (Minneapolis, MN) announced that it has reached two clinical program milestones for its CoreValve system in the United States. First, enrollment was completed in the study of high-risk patients in the company's CoreValve United States Pivotal trial. The total trial enrollment includes more than 1,500 patients with severe aortic stenosis who are at high or extreme risk for aortic valve surgery. Medtronic stated that it continues to enroll extreme risk patients in the trial as part of the US Food and Drug Administration (FDA) continued-access policy and is seeking approval to continue enrolling high-risk patients under this policy.

Second, 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. US patient enrollment is expected to begin within weeks, the company stated.

David H. Adams, MD, serves as national co-principal investigator of both the CoreValve US Pivotal trial and SURTAVI trial. He is chair of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center in New York City. In addition to Dr. Adams, SURTAVI principal investigators in the United States are Jeffrey Popma, MD, and Michael Reardon, MD.

“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 US Pivotal trial and SURTAVI trial are landmark trials that will provide critical insights about the appropriate use of the self-expanding CoreValve system,” commented Dr. Adams in the Medtronic press release. “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.”

According to Medtronic, the CoreValve US Pivotal trial has enrolled more than 1,500 patients in two studies (high- and extreme-risk) led by heart teams made up of interventional cardiologists and cardiac surgeons at 45 leading clinical institutions across the United States. Approximately two-thirds of trial patients are in the high-risk study. The primary endpoint for the high-risk study is freedom from all-cause death at 12 months, and the primary endpoint for the extreme-risk study is freedom from all-cause death or major stroke within 12 months.

The SURTAVI trial is a global, randomized, controlled trial on transcatheter aortic valve implantation that will evaluate approximately 2,500 patients. The trial will evaluate the potential for the CoreValve system to be considered for less-sick patients who typically are treated with surgical aortic valve replacement today. Within the SURTAVI trial, CoreValve implantation can be performed by transfemoral, subclavian, or direct aortic access, depending on the needs of the patient. Selection of intermediate risk surgical patients will be based on the Society of Thoracic Surgeons mortality risk of ≥ 4% and ≤ 10%, and the study's primary endpoint will be a composite of all-cause mortality and disabling stroke at 24 months. All patients will be followed through 5 years.