The Medtronic CoreValve System with the AccuTrak stability layer will be investigated in two independent studies.
The CoreValve System is designed to provide a minimally invasive, non-surgical treatment option for patients with symptomatic, severe aortic stenosis who are at high risk or are ineligible for open-heart surgery.
Medtronic CoreValve US pivotal trial co-principal investigator Jeffrey Popma said that there is a distinct need for a new treatment option for many older patients with a severely diseased aortic heart valve and, as the population ages, this need continues to grow.
The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously, usually through the femoral artery, without open-heart surgery or surgical removal of the native valve, Medtronic said.
