Core Valve for Aortic Stenosis is FDA approved-Medtronic

Medtronic, Inc. announced the FDA approval of 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. Untreated, these patients have a risk of dying approaching 50 percent at one year.

The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, 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 Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the corevalve than was expected based on a performance goal developed in partnership with the fda. 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 CoreValve patents have been challenged in litigation brought by Edwards Lifesciences, makers of the Sapien and Cribier Aortic Valves.