Medtronic reports the start of THRIVE, the company's US post-market clinical study of its Talent Thoracic Stent Graft for the endovascular repair of thoracic aortic aneurysms.
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 US Food and Drug Administration (FDA) approval, THRIVE will enroll a total of 451 patients at a minimum of 15 US 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. 'THRIVE will gather clinically-relevant data on the long-term safety and efficacy of the Talent Thoracic Stent Graft in a real-world, US patient population,' said Dr Karthikeshwar Kasirajan, the principal investigator of THRIVE, and leader of the team that performed the first study Implant on April 20 at Emory University Hospital in Atlanta. 'In my experience, the Talent Thoracic Stent Graft System offers controlled deployment for placement accuracy, and enables more patients to be treated due to its broad range of diameters.' THRIVE has been designed to evaluate how the benefits of the Talent Stent Graft translate into clinical differences in routine practice. With more than 10 years of clinical use worldwide, the Talent Thoracic Stent Graft has been implanted in more than 20,000 patients. The device was approved by the FDA in June 2008. The features of the Talent Thoracic Stent Graft with the Xcelerant Delivery System include a broad range of diameters to treat a variety of anatomies; controlled deployment for easy and accurate Stent Graft placement; as well as high overall radial force for secure fixation.
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