Medtronic Initiates Study of Recapturable CoreValve Evolut R TAVR System

October 22, 2013—Medtronic, Inc. (Minneapolis, MN) announced the first implantations in the CoreValve Evolut R clinical study, which will evaluate the safety and effectiveness of the new Medtronic CoreValve Evolut R recapturable transcatheter aortic valve replacement (TAVR) system.

According to Medtronic, the CoreValve Evolut R is a recapture-enabled valve and delivery system that offers new capabilities 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 TAVR.

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 surgical aortic valve replacement. Patients will be enrolled at Monash Medical Centre-Southern Health in Melbourne, Australia; University Hospital Bonn in Bonn, Germany; St. George's Hospital in London, England; 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 7 days. Secondary endpoints include recapture success rate, when attempted, and hemodynamic performance.

Ian Meredith, MD, of Monash Medical Centre, is the Principal Investigator and implanted the first devices in the study. In the company's press release, Dr. Meredith commented, “CoreValve has set a high bar for rates of procedural success, which have been confirmed in both real-world use and clinical studies such as CoreValve ADVANCE. We are studying this recapture-enabled valve and low-profile delivery system to provide design enhancements that further increase procedural confidence and, ultimately, improve patient care.”

Medtronic stated that the new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R recapturable delivery system. The valve is 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 has a new InLine sheath that significantly reduces the profile of the catheter required to access the patient vessel. Its 1:1 delivery response is designed to provide first-time valve placement accuracy during deployment.

The company advised that the CoreValve Evolut R and EnVeo R recapturable system are not currently approved for commercial use. The CoreValve system is not currently approved for commercial use in the United States, where it is currently undergoing clinical trials, noted Medtronic.