AAA devices
This article was originally published in The Gray Sheet
Executive Summary
FDA approval of the Talent abdominal aortic aneurysm endovascular stent graft is expected by August 2002, the beginning of the firm's second fiscal quarter, Rasdal says. Medtronic currently is in discussions with the agency, following the completion of U.S. clinical trials. The device is the top-selling thoracic stent graft outside the U.S., Medtronic claims. Because the Talent is made from drawn nitinol wire, it should be more suitable for patients with aortic tortuosity than the firm's AneuRx AAA device, which FDA approved in September 1999, Rasdal suggested. Further back in development is a second-generation device, expected to be approved in the U.S. in the spring of 2004, that will leverage the "best" attributes of both the Talent and the AneuRx, according to Rasdal. The company expects the U.S. AAA market to grow to more than $600 mil. by Medtronic's 2006 fiscal year (beginning May 1), driven by an increased diagnosis of aortic aneurysms and a heightened acceptance of intravascular stent grafts