October 22, 2013 — Medtronic Inc. announced the first implants in the CoreValve Evolut R clinical study, which will evaluate the safety and effectiveness of the CoreValve Evolut R recapturable system. This recapture-enabled valve and delivery system is 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 (TAVI).
“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,” said Ian Meredith, M.D., Monash Medical Centre, Southern Health, Melbourne, Australia and principal investigator in the study. Meredith implanted the first devices. “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.”
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 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 one-to-one delivery response is designed to provide first-time valve placement accuracy during deployment. The new system builds on experience from more than 45,000 CoreValve system implants worldwide.
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 and is currently undergoing clinical trials.
For more information: www.medtronic.com