News | September 07, 2010

Enhanced Transcatheter Valve Delivery System Gains European Approval

September 7, 2010 – European CE mark approval was granted for a new Medtronic CoreValve delivery system with AccuTrak Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValve device. This next-generation technology builds upon the CoreValve system that first received CE mark in March 2007.

CoreValve and AccuTrak are not yet available in the United States, Canada or Japan for investigational or commercial sale or use.

“The AccuTrak Stability Layer is a valuable advancement for CoreValve, which already offers a unique self?expanding design to control the positioning and release of the valve,” said professor Rüdiger Lange, M.D., Ph.D., director of cardiovascular surgery at The German Heart Centre in Munich, Germany. His center was among the first to use the new delivery system with the AccuTrak Stability Layer in a CoreValve implantation. “This system makes it easier to precisely position the CoreValve device, which can be important to achieving positive procedure outcomes. The increased accuracy and control with the new delivery system may also make it even easier to train physicians to perform TAVI procedures.”

Leading interventional cardiologists who were the first to use the AccuTrak Stability Layer in a CoreValve implant included: Ulrich Gerckens, M.D., with Helios Klinikum Siegburg ? Heart Center in Siegburg, Germany; Axel Linke, M.D. and Gerhard Schuler, M.D. with Herzzentrum Leipzig, University Leipzig in Leipzig, Germany; and Stephan Windecker, M.D., with University Hospital in Bern, Switzerland.

Medtronic said this is the first of many planned CoreValve system enhancements.

The CoreValve system is designed to treat severe aortic valve stenosis without open?heart surgery or surgical removal of the native valve. It has now been implanted in more than 10,000 patients worldwide in 34 countries outside the United States. Typically delivered through the femoral artery, CoreValve is used in 75 percent of transarterial transcatheter valve replacement procedures.

For more information: www.corevalve.com

Related Content

Foldax Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) so the company to initiate a U.S. clinical study of its Tria biopolymer mitral surgical heart valve.
News | Heart Valve Technology | December 14, 2020
December 14, 2020 - Foldax Inc. today announced that the U.S.

The Edwards Lifesciences Sapien 3 TAVR valve. The annual volume of TAVR has increased each year and in 2019 TAVR volume (72,991) exceeded all forms of SAVR (57,626), coinciding with the U.S. Food and Drug Administration (FDA) approval of TAVR for low-risk patients. 

Feature | Heart Valve Technology | November 17, 2020
November 17, 2020 — Since the approval of the first transcatheter aortic valve replacement (TAVR) device in 2011, mor
oston Scientific Corp. announced today it is immediately retiring the entire Lotus Edge transcatheter aortic valve replacement (TAVR) system. It also initiated a global, voluntary recall of all unused inventory of the Lotus Edge due to complexities associated with the product delivery system. 
Feature | Heart Valve Technology | November 17, 2020 | Dave Fornell, Editor
November 17, 2020 — Boston Scientific Corp.
The Keystone Heart TriGuard 3 (TG3) is a self-stabilizing cerebral embolic deflection filter used in patients undergoing transcatheter aortic valve replacement (TAVR). The device is designed to reduce TAVR complications of cerebral embolization and ischemic stroke. #TCT #TCT2020 #TCTconnect

The Keystone Heart TriGuard 3 (TG3) is a self-stabilizing cerebral embolic deflection filter used in patients undergoing transcatheter aortic valve replacement (TAVR). The device is designed to reduce TAVR complications of cerebral embolization and ischemic stroke. 

News | Heart Valve Technology | October 15, 2020
October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of the Keystone Heart
The Boston Scientific Acurate neo self-expanding TAVR valve (left) did not perform as well clinically as the Medtronic CoreValve Evolut TAVR valve (right) in the SCOPE II trial presented at TCT 2020. #TCT #TCT2020 #TCTconnect

The Boston Scientific Acurate neo self-expanding TAVR valve (left) did not perform as well clinically as the Medtronic CoreValve Evolut TAVR valve (right) in the SCOPE II trial presented at TCT 2020.

Feature | Heart Valve Technology | October 15, 2020
October 15, 2020 – The SCOPE II trial comparing the Boston Scientific Acurate neo vs.
An illustration showing the MitraClip catheter entering the left atrium through a transseptal puncture. #TCT2020 #TCTconnect

An illustration showing the MitraClip catheter entering the left atrium through a transseptal puncture.

News | Heart Valve Technology | October 15, 2020
October 15, 2020 – The...
Medtronic is starting a randomized, head-to-head study comparing the Medtronic CoreValve Evolut Pro and Pro+TAVR Systems against the balloon-expandable Edwards Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valvestwo transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). 

Medtronic is starting a randomized, head-to-head study comparing the Medtronic CoreValve Evolut Pro and Pro+TAVR Systems against the balloon-expandable Edwards Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valvestwo transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). 

News | Heart Valve Technology | October 14, 2020
October 14, 2020 — Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter ao