Medtronic has received the US Food and Drug Administration (FDA) conditional approval for its investigational device exemption (IDE) application and pivotal clinical trial protocol to evaluate the CoreValve System for transcatheter aortic valve implantation (TAVI).
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.