The U.S. Food and Drug Administration (FDA) has approved the self-expanding transcatheter CoreValve System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery, according to an announcement made Jan. 17 by Medtronic, Inc.

The FDA based its approval on the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal trial presented at TCT 2013, which demonstrated that the CoreValve System is "safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported." The FDA granted approval of the device without an independent device advisory panel review.

The trial achieved its primary endpoint of a low rate of all-cause mortality or major stroke at one year. According to the announcement, at one month, the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. Pivotal Trial, demonstrated even better survival and stroke performance.

"The low rates of stroke and valve leakage with the CoreValve System – two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life – set a new standard for transcatheter valves," said Jeffrey J. Popma, MD, FACC, director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the Trial. "The CoreValve U.S. Pivotal Trial was rigorously designed and applied clinical best practices. The trial results have redefined optimal transcatheter aortic valve replacement (TAVR) outcomes in the areas that matter most to physicians and their patients, and the results are especially remarkable given the complex medical conditions and extreme frailty of this population."

According to the announcement, the FDA approved the entire CoreValve platform including the CoreValve Evolut(TM) 23mm, and the CoreValve 26mm, 29mm and 31mm valves.

Keywords: Stroke, United States Food and Drug Administration, Quality of Life, Cardiac Surgical Procedures