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

aortic valve reconstruction, surgery, PinnacleHealth, Pennsylvania
News | Cardiovascular Surgery| May 04, 2016
Three PinnacleHealth patients recently underwent a new procedure for aortic valve reconstruction using the patients'...
Feature | Business| April 28, 2016 | Dave Fornell
 
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings| April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
TAVR, Sapien 3, ACC.16
Feature | Heart Valve Repair| April 19, 2016 | Michael J. Rinaldi, M.D., FACC, FSCAI
The continuation of positive clinical trial data for transcatheter aortic valve repair (TAVR), showing it is equal to
Sapien III, Sapien 3, PARTNER II

The Sapien 3 valve has a skirt that has helped significantly reduce paravalvular leaks, which were an issue with earlier generation Sapien devices. 

Feature | Heart Valve Repair| April 15, 2016
April 15, 2016 — Intermediate-risk patients who received transcatheter aortic valve replacement (TAVR) with the lates
TAVR runoff image

A 3-D CT reconstruction of a TAVR run-off image to assess the femoral access route using Toshiba's Aquillion One and Vital Images advanced visualization technologies. 

Feature | Heart Valve Repair| April 15, 2016
April 15, 2016 — Accurate and precise anatomical information is crucial to successful transcatheter aortic valve repl
TAVR, Sapien 3, ACC.16

Implantation of an Edwards Lifesciences Sapien valve under angiography during the balloon inflation to expand the valve into the aortic annulus. 

Feature | Heart Valve Repair| April 15, 2016
April 15, 2016 —The more frequently a hospital performs a transcatheter aortic valve replacement (TAVR) the better pa
Sponsored Content | Videos | Heart Valve Repair| April 15, 2016
John Carroll, M.D., professor of medicine at the University of Colorado School of Medicine, and director of intervent
Sponsored Content | Videos | Heart Valve Repair| April 15, 2016
Chandan Devireddy, M.D., assistant professor of medicine at Emory Healthcare in Atlanta and an investigator in the PA
CABG, mitral valve repair, ischemic mitral regurgitation, IMR, study, ACC 2016
News | Structural Heart| April 11, 2016
Just-released two-year follow-up data comparing coronary-artery bypass grafting (CABG) with combined CABG and mitral-...
Overlay Init