The U.S. Food and Drug Administration has approved Minneapolis-based Medtronic's CoreValve Transcatheter for use without undergoing an independent device advisory panel review for the product, according to a Medtronic news release.
The self-expanding CoreValve Transcatheter is for use in severe aortic stenosis patients who are too weak for open-heart surgery.
The FDA decided to forgo the independent device advisory panel review because the initial clinical trial outcomes in the Extreme Risk Study showed "exceptional clinical performance," according to the news release.
In the Extreme Risk Study, the rate of death or major stroke was 25.5 percent, far below the performance goal of 43 percent. Additionally, severe aortic stenosis patients who do not receive treatment have about a 50 percent chance of surviving after one year. In the study, 75.6 percent of patients were alive after one year.
According to Medtronic, the CoreValve Transcatheter study reports some of the lowest rates of stroke and valve leakage.
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