The Evolut R System has been approved by the FDA for transcatheter aortic valve replacement (TAVR) for patients suffering from severe aortic stenosis, a condition that can lead to serious heart problems including heart failure.

NYU Langone Medical Center director of Interventional Cardiology Mathew Williams said: "In a short time, the TAVR procedure has become an established treatment option for high risk patients with severe aortic stenosis who are unable to undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes.

Based on the companys previous CoreValve System, CoreValve Evolut R System is designed to treat patients with aortic stenosis, a condition where the aortic valve narrows, limiting blood flow from the aorta to the rest of the body.

The new system is optimized to increase stability and sealing at the annulus, and maintaining supra-annular valve positioning for improved blood flow, and promote valve sealing at the annulus.

CoreValve Evolut R System is equipped with CoreValve Evolut R transcatheter valve and EnVeo R Delivery System, which features an InLine Sheath which decreases the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch).