Medtronic Gains Ce Mark For Enhanced Corevalve(R) Delivery Catheter System With Accutrak Stability Layer

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Cardiovascular / Cardiology;  Heart Disease
Article Date: 08 Sep 2010 - 0:00 PDT

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Medtronic, Inc. (NYSE: MDT) announced CE (Conformité Européenne) Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak™ Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak's proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValv device.¹ This next generation technology builds upon the CoreValve system that first received CE (Conformité Européenne) 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 Prof. Rüdiger Lange, M.D., Ph.D., director of cardiovascular surgery at The German Heart Centre in Munich, Germany, whose 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.

"AccuTrak is an exciting advancement that leverages proven technology and expertise from Medtronic's innovative cardiovascular prtfolio for the improvement of TAVI," said John Liddicoat, M.D., vice president and general manager of the Medtronic Structural Heart division. "This is the first of many planned CoreValve system enhancements that we expect will simplify the procedure, enhance clinical outcomes and expand patient access."

The CoreValve system, designed to treat severe aortic valve stenosis without open‐heart surgery or surgical removal of the native valve, 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.

¹ Medtronic AccuTrak Stability Layer performance was based on simulated use testing.

Source:
Medtronic, Inc.

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