Medtronic gains CE mark for enhanced CoreValve delivery catheter system with AccuTrak stability layer


Medtronic announced CE mark approval and the first global use and launch of the 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 CoreValve device. This next generation technology builds upon the CoreValve system. CoreValve and AccuTrak are not yet available in the US, 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. “This system makes it easier to precisely position the CoreValve device, which can be important in 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.”


“AccuTrak is an exciting advancement that leverages proven technology and expertise for the improvement of TAVI,” said John Liddicoat. “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 US. Typically delivered through the femoral artery, CoreValve is used in 75 percent of transarterial transcatheter valve replacement procedures.