Medtronic’s CoreValve TAVR System Approved for Patients at High Risk for Surgery
June 12, 2014—Medtronic, Inc. announced US Food and Drug Administration (FDA) approval of its self-expanding CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are at high risk for surgery.
Medtronic advised that the FDA approved the CoreValve system without the need for an independent device advisory panel review because of the exceptionally positive clinical results demonstrated in the High Risk Study of the CoreValve United States Pivotal Trial.
Based on the strength of the trial data, the FDA determined that sufficient information was available to evaluate the safety and efficacy of the Medtronic CoreValve system for both extreme-risk and high-risk patient groups without the need for external Advisory Committee panels. This milestone, along with the priority review designation, accelerated regulatory approvals for the CoreValve device.
The company stated that it worked closely with the FDA throughout the pivotal clinical trial and premarket approval review process. The FDA granted priority review designation for both patient groups in the premarket approval submissions. Priority designation is granted to new therapies of major public health interest, noted Medtronic.
Medtronic’s CoreValve system features a self-expanding frame that provides controlled deployment, enabling physicians to accurately place the valve inside a patient’s original valve while conforming to the native annulus to provide a seal. The FDA approved the entire CoreValve platform—including the 23-, 26-, 29-, and 31-mm size valves—all of which are delivered through an 18-F TAVR delivery system, making it possible to treat patients with difficult or small vasculature.
In January 2014, Medtronic announced FDA approval of the CoreValve system for patients at extreme risk. The device received European CE Mark in 2007.
According to Medtronic, the head-to-head study comparing TAVR with the CoreValve system to traditional surgical aortic valve replacement met its primary endpoint with high survival at 1 year for patients who were implanted with the CoreValve system (85.8%), which was statistically superior to patients who underwent a surgical valve (80.9%).
For patients treated with the CoreValve system in the High Risk Study, the rates of stroke were low and not statistically different than the rates experienced by surgery patients. The rate of major adverse cardiovascular or cerebral events was significantly better for CoreValve patients at 1 year, and overall hemodynamic performance was better in CoreValve patients than in surgery patients across all time points.
David H. Adams, MD, who is Chair of the Department of Cardiothoracic Surgery at the Mount Sinai Hospital in New York City, serves as National Coprincipal Investigator of the CoreValve United States Pivotal Trial.
In Medtronic’s press release, Dr. Adams commented, “This rigorous trial has defined a new standard for transcatheter valve performance, with superiority results that give physicians even more confidence in making TAVR treatment decisions. With this approval, we can treat more patients due to the broad range of CoreValve sizes, and we have an option compared to surgery that provides a greater chance for a longer life while minimizing the risk of stroke."