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

Prosthetic Valve Mismatches Common in TAVR Procedures
News | Heart Valve Technology | October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and...
Local Anesthesia Safe and Effective for Intermediate- and High-Risk TAVR Patients
News | Heart Valve Technology | September 28, 2018
The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (...
MitraClip Reduces Mortality for Heart Failure Patients With Secondary Mitral Regurgitation
News | Heart Valve Technology | September 26, 2018
Patients with heart failure and secondary mitral regurgitation (MR) who remained symptomatic despite maximally...
Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Gore Acquires Pipeline Medical Technologies Inc.
News | Heart Valve Technology | September 06, 2018
W. L. Gore & Associates Inc. (Gore) announced the acquisition of Pipeline Medical Technologies Inc., a privately...
The Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May.

The Edwards Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May, becoming the first transcatheter tricuspid repair device to be approved in the world.

Feature | Heart Valve Technology | August 21, 2018 | Jeff Zagoudis
The tricuspid valve has been dubbed “the forgotten valve” by many practitioners in the interventional cardiology spac
Earlier Intervention for Mitral Valve Disease May Lead to Improved Outcomes
News | Heart Valve Technology | July 26, 2018
The number of patients undergoing mitral valve operations are at an all-time high, and new research suggests many...
Overlay Init