FDA approves the CoreValve Evolut R System for aortic stenosis- Medtronic

Medtronic has announced the FDA approval and US launch of the new recapturable, self-expanding CoreValve Evolut R System. It is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery. The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R Delivery System, which features an InLine Sheath that significantly reduces the profile to the lowest on the market. A smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5.0 mm), through the preferred transfemoral access route, which may minimize the risk of major vascular complications in some patients.

Comment: In March, the CoreValve System was the first TAVR system to be approved in the U.S. for valve-in-valve procedures in patients whose surgical aortic heart valves have failed. Also in March, the highly anticipated two-year data from the High Risk Study of the CoreValve U.S. Pivotal Trial was presented at ACC.15, which showed superior survival benefit at two years for TAVR with the CoreValve System compared to patients who underwent surgical aortic valve replacement.