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:

Related Content

Neovasc Tiara, Reducer Transcatheter Devices Featured at CSI Frankfurt 2019 Conference
News | Heart Valve Technology | July 09, 2019
Neovasc Inc. announced that its Tiara transcatheter mitral valve replacement (TMVR) device and its Neovasc Reducer...
Study Shows Inducing a Heart Attack Helps Valve Patients
News | Heart Valve Technology | July 03, 2019
A study of a procedure developed at Henry Ford Health System shows inducing a heart attack in patients with heart...
CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement
Feature | Heart Valve Technology | June 24, 2019
The Centers for Medicare and Medicaid Services (CMS) recently finalized its decision to update the national coverage...
Abbott Tricuspid Valve Repair System Reduces Tricuspid Regurgitation at 30 Days
News | Heart Valve Technology | June 11, 2019
June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE...
DSM and SAT Partnering to Develop Next-Generation, Cost-Effective Heart Valve
News | Heart Valve Technology | June 04, 2019
Royal DSM recently announced a collaboration with Strait Access Technologies (SAT), to develop the world’s first...

The MitraClip is one example of a transcatheter mitral valve repair or replacement (TMVR) device used in the structural heart repair program at Henry Ford Hospital.

Podcast | Heart Valve Technology | May 31, 2019
Marvin Eng, M.D., structural fellowship director at Henry Ford Health System, and William O'Neill, M.D., director of
Illustration showing the catheter steps for the LAMPOON procedure designed to prevent left ventricular outflow tract (LVOT) obstruction . From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.

Figure 1: Illustration showing the catheter steps for the LAMPOON procedure. From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.

Feature | Heart Valve Technology | May 22, 2019
Researchers at the National, Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH
Edwards Announces Research Milestones for Pascal Transcatheter Mitral Valve Program
News | Heart Valve Technology | May 22, 2019
Edwards Lifesciences Corp. announced strategic clinical and regulatory milestones for its Edwards Pascal transcatheter...
Videos | Heart Valve Technology | May 20, 2019
A demonstration of how to calculate the neo-left ventricular outflow tract (neo-LVOT) on CT imaging for a transcathet
Study Finds TAVR Can Be Considered for Patients in All Surgical Risk Classes
News | Heart Valve Technology | May 08, 2019
Transcatheter aortic valve replacement (TAVR) has been studied as an alternative to surgical aortic valve replacement...
Overlay Init