Medtronic Starts Enrollment in THRIVE, U.S. Post-Market Study of the Talent™ Thoracic Stent Graft Lifesaving Medical Device Extends Benefits of Minimally Invasive Endovascular Repair of Aortic Aneurysms to More Patients

related stories: Drug-Eluting Stent Center FDA Approves Talent Thoracic Stent Graft external sites: Medtronic, Inc. Talent Thoracic Stent Graft     April 27, 2009 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT), today reported the start of THRIVE, the company’s U.S. post-market clinical study of its Talent Thoracic Stent Graft for the endovascular repair of thoracic aortic aneurysms. The acronym THRIVE stands for Descending Thoracic Aortic Aneurysm Endovascular Repair Post Approval Study An aortic aneurysm is a dangerous bulge or weakness in the body’s main artery. Untreated, aortic aneurysms can burst, commonly resulting in death due to extensive internal bleeding. Thoracic aortic aneurysms affect nearly 10 of every 100,000 elderly people in the United States. Thoracic endovascular aortic repair (TEVAR) is a minimally invasive procedure in which a stent graft – a fabric tube reinforced with metal springs – is threaded through the femoral artery and expanded at the site of the aneurysm. Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm and the risk of rupture. The alternative to TEVAR is open surgical repair. Addressing a condition of U.S. Food and Drug Administration (FDA) approval, THRIVE will enroll a total of 451 patients at a minimum of 15 U.S. sites. The study’s primary endpoint is freedom from aneurysm-related mortality (ARM) at five years, with ARM defined as death from aneurysm rupture or from any procedure intended to treat the segment targeted by the Talent Thoracic Stent Graft System. The study design incorporates the test group of 195 subjects from the earlier study that supported the device’s FDA approval in 2008, as well as an additional 256 new subjects to be prospectively enrolled. All subjects will be followed for five years.

 source