Medtronic Announces First Implants In CoreValve Evolut R Clinical Study

(RTTNews) - Medtronic Inc. (MDT) announced the first implants in the CoreValve Evolut R Clinical Study, which will evaluate the safety and effectiveness of the new Medtronic CoreValve Evolut R Recapturable System. This recapture-enabled valve and delivery system offers new capabilities that are designed to advance deliverability and valve performance while providing the option to recapture and reposition the CoreValve Evolut R valve during deployment, if needed, while performing transcatheter aortic valve implantation or TAVI.

In addition to Monash Medical Centre, the prospective CoreValve Evolut R Clinical Study will enroll up to 60 patients with severe symptomatic aortic stenosis who are considered at high risk for open-heart surgical aortic valve replacement at University Hospital Bonn in Bonn, Germany, St. George's Hospital in London, and Royal Victoria Hospital in Belfast, Northern Ireland.

The primary endpoints are all-cause mortality and stroke at 30 days, as well as device success rate at 24 hours to seven days. Secondary endpoints include recapture success rate, when attempted, and hemodynamic performance.

The company said that the new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R Recapturable Delivery System. The new valve is anatomically designed to provide conformability at the annulus for optimal annular fit and sealing, while maintaining supra-annular valve function for strong hemodynamic performance.

The EnVeo R delivery system offers a new InLine Sheath, significantly reducing the profile of the catheter required to access the patient vessel, and its 1:1 delivery response is designed to provide first-time valve placement accuracy during deployment.