FDA Expands CoreValve Indication for High-Risk Patients

Accelerated approval obtained after clinical outcomes with self-expanding valve prove superior to surgical aortic valve replacement at one year


June 12, 2014
corevalve, FDA, high risk patients, TAVR

The U.S. Food and Drug Administration (FDA) expanded the indicated use for the CoreValve self-expanding transcatheter aortic valve system for patients with severe aortic stenosis who are at high risk for surgery. CoreValve originally gained FDA clearance in January for patients at extreme risk for surgical valve replacement. This new approval is based on groundbreaking data that showed clinical outcomes at one year with the CoreValve system were superior to the current gold standard of open-heart surgery. 

The FDA approved the CoreValve for high-risk patients without the need for an independent device advisory panel review due to its exceptionally positive clinical results demonstrated in the high-risk study of the CoreValve U.S. pivotal trial. The head-to-head study, comparing transcatheter aortic valve replacement (TAVR) with the CoreValve system to traditional surgical aortic valve replacement, met its primary endpoint with high survival at one year for patients receiving the CoreValve (85.8 percent), which was statistically superior to patients receiving a surgical valve (80.9 percent).  

The CoreValve system was designed to serve the clinical needs of the broadest range of patients with aortic stenosis. The valve’s self-expanding frame provides controlled deployment, enabling physicians to accurately place the valve inside a patient’s original valve, while conforming to the native annulus to provide a seal. The FDA approved the entire CoreValve platform, including the 23, 26, 29 and 31 mm size valves. All of these sizes are delivered through an 18 French delivery system, which is the smallest commercially available TAVR delivery system.

Since receiving CE mark in 2007, the CoreValve system has been implanted in more than 60,000 patients in more than 60 countries.

For more information: www.corevalve.com