Medtronic announced that the FDA has approved the CoreValve System for patients with severe aortic stenosis who are at high risk for surgery.
The CoreValve System is a self-expanding transcatheter that allows controlled deployment and accurate placement of the valve.
The approval was based on positive data from the High Risk Study of the CoreValve U.S. Pivotal Trial. The study compared transcatheter aortic valve replacement (TAVR) with the CoreValve System to traditional surgical aortic valve replacement. Data showed the study met its primary endpoint with high survival at 1 year for patients receiving the CoreValve System (85.8%), which was statistically superior to patients receiving a surgical valve (80.9%).
In January 2014, the CoreValve System was approved for patients at extreme risk. The FDA granted Priority Review Designation for both the Extreme Risk and High Risk PMA submissions. The CoreValve System includes 23mm, 26mm, 29mm, and 31mm sizes, all delivered through the smallest TAVR delivery system (18Fr).
For more information call (877) 526-7890 or visit CoreValve.com.