Medtronic has begun its CoreValve U.S. pivotal trial in the U.S., to assess whether the system could be an alternative treatment to open-heart surgery for patients with severe aortic stenosis who are not surgical candidates.
The system will be investigated in more than 1,200 patients at up to 40 U.S. clinical trial sites, according to the Minneapolis-based company, which received conditional FDA approval for its investigational device exemption application for the trial in October 2010.
The first CoreValve transcatheter aortic valve implantation procedure was performed by David H. Adams, MD, and Samin K. Sharma, MD, at Mount Sinai Medical Center in New York City. A second CoreValve case took place this week at El Camino Hospital in Mountain View, Calif.; St. Francis Hospital, the Heart Center in Roslyn, N.Y., also has been activated in the trial and is screening patients.
Jeffrey J. Popma, MD, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, is the national co-principal investigator of the Medtronic CoreValve U.S. pivotal trial along with Adams.