The FDA gave CoreValve its blessing, approving the device in patients with severe aortic stenosis who are considered too high risk of death for standard open-heart surgery and instead undergo transcatheter aortic valve replacement (TAVR).

CoreValve’s approval was widely anticipated after Medtronic announced that the FDA planned to make its decision without the assistance of an advisory panel. Medtronic’s announcement followed release of safety and efficacy results of its pivotal CoreValve Extreme Risk Iliofemoral study at the Transcatheter Cardiovascular Therapeutics (TCT) scientific session in San Francisco in late 2013.

The study, in which surgeons implanted the CoreValve system in 471 patients with symptomatic severe aortic stenosis during TAVR, found all-cause mortality or major stroke rates of 9.3 percent at one month and 25.5 percent at 12 months; mortality rates of 7.9 percent at one month and 24 percent at one year; and major stroke rates of 2.4 percent at one month and 4.1 percent at one year.

Major vascular complication rates totaled 8.3 percent at one month and 8.5 percent at one year and mild paravalvular leak rates were 11.5 percent at one month and 4.1 percent at one year. The study showed a permanent pacemaker rate of 22.2 percent at one month. 

With approval of the CoreValve System, surgeons and their patients will now have an option of devices. Previously, Edwards Lifesciences had the only TAVR device approved in the U.S. with its Sapien system. The FDA had approved Sapien for the treatment of inoperable patients in November 2011 and in high-risk aortic stenosis patients in October 2012.

The FDA’s approval covers the entire CoreValve platform, including the CoreValve Evolut(TM) 23mm, and the CoreValve 26mm, 29mm and 31mm valves, and an 18Fr TAVR delivery system.

The ongoing High Risk Study of the CoreValve U.S. Pivotal Trial compares the CoreValve System to traditional open heart surgery. Results from this trial will be used if Medtronic seeks approval for patients with severe aortic stenosis who are at high operative risk.