The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting.
The approval was based largely on results from the Extreme Risk Study of the CoreValve U.S. Pivotal Trial. As previously reported here, the rate of death or major stroke at one year was 25.5%, which was 40.7% lower than the prespecified performance goal of 43% (p<0.0001) based on historical standards. All-cause mortality was 7.9% at 30 days and 24% at 1 year. Cardiovascular mortality was 7.9% and 17.9%. The rate of major stroke was 2.4% at 30 days and 4.1% at 1 year.
“The low rates of stroke and valve leakage with the CoreValve System – two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life – set a new standard for transcatheter valves,” said Jeffrey J. Popma, co-principal investigator of the trial, in a press release.
Medtronic said the FDA had approved the entire CoreValve platform, including 23mm, 26mm, 29mm and 31mm sizes.
CoreValve will now compete in the US marketplace with the Edwards Sapien device. Edwards anticipates approval this year of its next generation device, the Sapien XT. Edwards and Medtronic are locked in a bitter and wide-ranging dispute over patents. Earlier this week in the latest round of the fight a federal jury awarded Edwards $394 million from Medtronic.