Medtronic has commenced an international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.
The CoreValve Advance clinical study began enrolling patients in the past several weeks, with the first two implants occurring in Germany. CoreValve Advance is a prospective, observational international post-market study to evaluate clinical outcomes of patients with severe aortic stenosis who are treated with the CoreValve system in standard clinical practice.
Approximately 1,000 patients with severe aortic stenosis will be enrolled in CoreValve Advance at up to 90 clinical trial sites in countries where the CoreValve system is commercially available. Most of the trial sites will be in Europe, where the CoreValve system is used in transcatheter aortic valve replacements involving percutaneous femoral access.
The CoreValve system received CE Mark in March 2007, and is not available in the U.S. for commercial sale or clinical use.