FDA Approves Medtronic's CoreValve for Inoperable Patients


January 17, 2014

MINNEAPOLIS, MN — The US Food and Drug Administration has approved the CoreValve (Medtronic, Minneapolis, MN) transcatheter heart valve for patients unable to undergo aortic-valve surgery[1]. The FDA approved the entire CoreValve platform, including the 23-mm, 26-mm, 29-mm, and 31-mm valves.

The approval is based on the results of the CoreValve Extreme Risk trial, a study of patients too sick or too frail to be treated with conventional aortic-valve replacement surgery. Use of the self-expanding transcatheter aortic valve in the trial was shown to be safe and effective. The results also showed that use of the transcatheter aortic-valve replacement (TAVR) system led to some of the lowest stroke and paravalvular leak rates seen in any study to date.

The results of the CoreValve Extreme Risk study were presented at TCT 2013 by Dr Jeffrey Popma (Beth Israel Deaconess Medical Center, Boston, MA) and reported by heartwire at the time. The study met its primary end point of reduction in all-cause death or major stroke. At one year, the rate of death or major stroke was 25.5%, which was 40.7% lower in the CoreValve-treated patients than expected based on performance measures developed by the FDA. At one year, 75% of patients were alive. As reported, use of the device was associated with pacemaker implantation in more than one in five patients.

The approval of the CoreValve occurred without an independent FDA advisory panel review. In 2013, the FDA announced it would not require an advisory committee to weigh in on whether the data supported approval, stating that data from the extreme-risk cohort would be sufficient.

Interestingly, a federal jury decided this week that the Medtronic CoreValve infringes on Edwards Lifesciences' Cribier transcatheter heart valve patent. As reported by heartwire , Edwards plan to pursue a court injunction that would prevent the sale of the CoreValve. Medtronic plans to appeal the ruling and oppose an injunction request by Edwards. A Medtronic spokesperson told heartwire today that the company "will comply with any court order" and that "if an injunction were issued, we would appeal it."


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