FDA Approves Pivotal Trial for Medtronic's CoreValve System

October 15, 2010—Medtronic, Inc. (Minneapolis, MN) announced that the US Food and Drug Administration granted conditional approval for the company's investigational device exemption application and pivotal clinical trial protocol to begin evaluating the CoreValve system for transcatheter aortic valve implantation (TAVI).

According to the company, the CoreValve system provides a minimally invasive, nonsurgical treatment option for patients with severe symptomatic aortic stenosis, who are at high risk or are ineligible for open heart surgery. The self-expandable technology is designed to replace a diseased aortic valve percutaneously, usually through the femoral artery. The CoreValve system will soon be implemented under investigational use and is not yet commercially available in the United States. The device received CE Mark approval in March 2007.



“There is a distinct need for a new treatment option for many older patients with a severely diseased aortic heart valve, and as the population ages, this need continues to grow,” commented Jeffrey Popma, MD, principal investigator for the Medtronic CoreValve pivotal trial in the United States.

Coprincipal investigator David H. Adams, MD, added, “This study represents a significant opportunity to fundamentally change the way we treat Americans with severe aortic stenosis. Cardiologists and cardiac surgeons will collaborate more closely than ever before to carefully select and deliver this innovative therapy.”

The CoreValve system with the AccuTrak stability layer will be investigated in two independent studies. Together, the two studies will enroll more than 1,200 patients at 40 clinical sites in the United States, which will be identified on the National Institutes of Health clinical trials Web site, www.clinicaltrials.gov, when they begin enrolling patients. The studies will evaluate the treatment's safety and efficacy in two groups of patients with severe aortic stenosis: those who have been diagnosed as high risk for aortic valve surgery and those who have been diagnosed as extreme risk for aortic valve surgery (ie, inoperable).

Patients who are considered at high surgical risk will be randomized one-to-one to either TAVI with CoreValve or to surgical aortic valve replacement. The primary endpoint for this trial is freedom from all-cause mortality at 12 months. Study participants who are deemed to be at extreme risk for surgical valve replacement will be randomized two-to-one to receive either TAVI with CoreValve or optimal medical management. This trial has coprimary endpoints of all-cause death or major stroke occurring within a minimum of 12 months of follow-up and a composite of all-cause death, major stroke, days of hospitalization for aortic valve disease, and number of hospitalizations for aortic valve disease occurring within a minimum of 12 months of follow-up, stated Medtronic.