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

FDA Approves IDE Study for Foldax Biopolymer Heart Valve Platform
News | Heart Valve Technology | February 18, 2019
Foldax Inc. announced the U.S. Food and Drug Administration (FDA) has granted investigative device exemption (IDE)...
Thubrikar Announces First-in-Human Implant of Optimum TAVI System
News | Heart Valve Technology | January 29, 2019
Thubrikar Aortic Valve Inc. announced the first human implant of the Optimum TAV using their transcatheter aortic valve...
Perceval Valve Offers Performance, Economic Advantages in Aortic Disease Treatment
News | Heart Valve Technology | January 29, 2019
LivaNova PLC announced the publication of three separate studies highlighting the performance of its sutureless aortic...
First Tendyne Transcatheter Mitral Valve Implanted in New York
News | Heart Valve Technology | January 28, 2019
Lenox Hill Hospital is the first hospital in New York City to successfully implant Abbott’s Tendyne transcatheter...
Boston Scientific, Edwards Lifesciences Agree To Global Litigation Settlement
News | Heart Valve Technology | January 15, 2019
Boston Scientific Corp. and Edwards Lifesciences Corp. announced that the companies have reached an agreement to settle...
The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as a arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital. Dr. Dominick Wiktor. The TEE is from a Philips Epiq system.

The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as an arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital.

Feature | Heart Valve Technology | January 14, 2019 | Allen Atchley, M.D., FACC, The Chattanooga Heart Institute
Mitral regurgitation (MR) is one of the most common types of heart valve diseases in the United States, affecting app
JC Medical Announces First U.S. Treatment With J-Valve TAVR Device
News | Heart Valve Technology | January 07, 2019
January 7, 2019 — JC Medical announced the successful treatment of the first U.S.
Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Technology | Heart Valve Technology | January 02, 2019
Edwards Lifesciences Corp. announced that the Sapien 3 Ultra system has received U.S. Food and Drug Administration (FDA...
Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation
Feature | Heart Valve Technology | December 12, 2018
A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S....
Overlay Init