FDA Approves CoreValve for Patients at High Risk for Surgery

The U.S. Food and Drug Administration (FDA) has given accelerated approval of the self-expanding transcatheter CoreValve System for patients with severe aortic stenosis who are at high risk for surgery, according to an announcement made June 12 by Medtronic, Inc.

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The FDA gave its approval due to the positive results reported in the High Risk Study of the CoreValve U.S. Pivotal Trial, which compared transcatheter aortic valve replacement (TAVR) with the CoreValve System to traditional surgical aortic valve replacement, and "met its primary endpoint with high survival at one year for patients receiving the CoreValve System (85.8 percent), which was statistically superior to patients receiving a surgical valve (80.9 percent)."

According to David H. Adams, MD, FACC, professor and chairman of the Department of Cardiothoracic Surgery at Mount Sinai Medical Center and co-principal investigator of the study, the trial was "the first prospective study of any device that suggests TAVR is superior to [surgery] in a predefined population of patients, and that's a provocative finding." He emphasized the "outstanding outcomes" in the surgical arm: "The low mortality rates with conventional surgery far exceeded the predicted mortality according to the Society of Thoracic Surgeons predictive model. In order to pass a superiority threshold, transcatheter treatment with the CoreValve device had to exceed excellent surgical outcomes."

According to the announcement, "the entire CoreValve platform was approved – including the 23mm, 26mm, 29mm and 31mm size valves – all of which are delivered through the smallest commercially available TAVR delivery system (18Fr), making it possible to treat patients with difficult or small vasculature."

The CoreValve System was previously approved by the FDA for patients at extreme risk in January 2014.

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