Feature | October 22, 2013

Medtronic Initiates Clinical Study of Recapturable Transcatheter Valve

heart valve repair medtronic corevalve evolut recapturable

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

Related Content

Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve
News | Heart Valve Technology| May 24, 2017
May 24, 2017 — Late-breaking data presented at EuroPCR 2017 demonstrating excellent clinical outcomes for...
Nearly One-Quarter of Patients Say Mechanical Heart Valve Disturbs Sleep
News | Heart Valve Technology| May 19, 2017
Nearly one-quarter of patients with a mechanical heart valve say it disturbs their sleep, according to research...
Analysis Looks at Role Type of Valve Plays in Patient Outcomes Post-TAVR
News | Heart Valve Technology| May 15, 2017
For patients who undergo transcatheter aortic valve replacement (TAVR), their risk factors, not the type of valve used...
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Implants CoreValve Evolut Pro Valve
News | Heart Valve Technology| May 03, 2017
The Baylor Jack and Jane Hamilton Heart and Vascular Hospital (BHVH) transcatheter aortic valve replacement (TAVR) team...
Alabama Medical Center First in Southeast to Offer CoreValve Evolut Pro TAVR Device
News | Heart Valve Technology| April 20, 2017
The Structural Heart Program at Princeton Baptist Medical Center, (Birmingham, Ala.) recently became the first center...
Updated AATS Guidelines Help Cardiovascular Surgeons Navigate Challenges of Managing Ischemic Mitral Regurgitation
News | Heart Valve Technology| April 20, 2017
April 20, 2017 — Mitral regurgitation can occur in up to 50 percent of patients with ischemic heart disease and even
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
Boston Scientific is buying TAVI valve maker Symetis, which has European approval for its Acurate Neo valve

The Symetis Acurate Neo TAVI valve.

News | Heart Valve Technology| April 11, 2017
April 10, 2017 — Boston Scientific recently announced a $435 million cash deal to acquire Symetis SA, a privately-hel
Sponsored Content | Videos | Heart Valve Technology| March 24, 2017
Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart and Vascular Center, di
Overlay Init