In a long-awaited decision, the FDA has granted Medtronic conditional approval for its investigational device exemption application, and the clinical trial is designed to evaluate the safety and efficacy of the CoreValve system for transcatheter aortic valve implantation (TAVI).
According to the Minneapolis-based company, the CoreValve technology is minimally invasive and is used as an alternative treatment method for patients with symptomatic, severe aortic stenosis who are at high-risk or ineligible for open-heart surgery.
The current clinical trial will enroll 1,200 patients at 40 clinical sites to assess the safety of the CoreValve system in two groups: patients with severe aortic stenosis at high-risk for aortic valve surgery and those unable to undergo aortic valve surgery. The patients will be randomized to receive TAVI treatment via the CoreValve or surgical aortic valve replacement.
The primary endpoint will measure rates of mortality at 12 months. Additionally, the researchers will report on the composite of all-cause death, major stroke, days of hospitalization for aortic valve disease and hospitalizations for aortic valve disease, which occur 12 months after follow-up.
The CoreValve system received a CE mark in March 2007 and has since been implemented in 12,000 patients across 34 countries. In February 2009, Medtronic purchased the Irvine, Calif.-based CoreValve for $700 million, despite the lack of U.S. regulatory approval