FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic Releases Data From CoreValve Clinical Trial

Oct. 14, 2015

Irish device giant Medtronic released positive results of a clinical trial evaluating one-year outcomes for the CoreValve transcatheter aortic valve replacement system in new patient populations with significant comorbidities.

The data on 109 patients with failed surgical valves showed an all-cause mortality rate of 13.4 percent and a major stroke rate of 3.1 percent.

For patients with end-stage renal disease, the rate of all-cause mortality was 30.3 percent, lower than the 41 percent for patients undergoing dialysis in the Transcatheter Valve Therapy Registry, Medtronic says.

The study also examined patients with low gradient aortic stenosis and found those treated with the self-expanding valve also had a low rate of all-cause mortality and major stroke. — Michael Cipriano