CE Mark and First US Implant for Medtronic’s Re-Sheathable CoreValve

Medtronic, Inc. has gained CE Mark approval for the 23 mm CoreValve® Evolut™ R System for transcatheter aortic valve implantation (TAVI). At the same time the company announced the first U.S. implants in the CoreValve Evolut R Clinical Study, which will evaluate the safety and effectiveness of the new system.

Background

Medtronic says its novel, self-expanding valve and 14FR equivalent delivery system offers new capabilities that advance valve performance and deliverability during the procedure, while providing the option to recapture (re-sheath the valve back into the catheter) and reposition (move the valve to a new position either above or below its current placement) the valve during deployment phase, if needed.

The novel system consisting of the CoreValve Evolut R transcatheter aortic valve and the EnVeo™ R Delivery Catheter System is designed for first-time positioning accuracy and also offers a new InLine(TM) Sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch); a smaller profile size is believed to minimize the risk of major vascular complications. The new valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing, while maintaining supra-annular valve position for improved hemodynamic performance.

Physician comments 

“The CoreValve Evolut R System offers improvements to a proven TAVI technology platform,” said Eberhard Grube, M.D., head, Center of Innovative Interventions in Cardiology (CIIC), University Hospital Bonn, Germany. “The system’s new recapture-enabled capabilities and advancements in valve delivery provide physicians with added procedural confidence. It’s a significant advance to know there is the option to redeploy the valve in the ideal position if necessary.”

Company comments

“Built on the proven foundation and procedural success of the CoreValve System with more than 65,000 implants worldwide, the CoreValve Evolut R System is the future of transcatheter aortic valve replacement,” said Rhonda Robb, vice president and general manager, Heart-Valve Therapies, Medtronic. “A truly next-generation device, CoreValve Evolut R provides heart teams with meaningful advancements that will increase the potential for optimal device placement.”

Source: Medtronic, Inc.

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