CoreValve Gains New Indication for High-Risk Patients — Physician’s First Watch
CoreValve Gains New Indication for High-Risk Patients
By Larry Husten
Medtronic's CoreValve system gained a second indication from the FDA for use in patients with severe aortic stenosis who are at high risk for surgery. The transcatheter aortic valve replacement (TAVR) system was initially approved earlier this year for use in patients who were too ill or frail for traditional open heart surgery.
The new approval is based on results from the U.S. CoreValve High-Risk Study published in the New England Journal of Medicine. In the trial, 795 patients with severe aortic stenosis who were at high risk for surgery were randomized to surgical aortic valve replacement (SAVR) or CoreValve. At 1 year, the rate of death was 14.2% in the TAVR group versus 19.1% in the SAVR group, a difference that was highly significant for noninferiority and even reached significance for superiority.
Adapted from CardioExchange.