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Medtronic Initiates VITALITY Study For The Talent Abdominal Stent Graft

Medtronic, Inc. reported the first enrollment in VITALITY, the company’s post-market clinical study of its Talent Abdominal Stent Graft for the endovascular repair of abdominal aortic aneurysms. “VITALITY will gather clinically relevant data on the safety and efficacy of the Talent Abdominal Stent Graft in a real-world US patient population,” said vascular surgeon Dr. George Pliagas, who led the team at St. Mary’s Medical Center in Knoxville that performed the first study implant on December 29, 2008. “Internationally, the device and delivery system have an excellent track record,” Dr. Pliagas added. “The Talent Stent Graft System is known to be accurate, durable and easy to use, and I expect that US physicians will have similar sentiments as it gains broader market acceptance.” The Talent Abdominal Stent Graft expands the applicability of endovascular aneurysm repair (EVAR), enabling more patients to benefit from a minimally invasive alternative to open surgical repair. It is the only stent graft approved by the FDA for use in the treatment of abdominal aortic aneurysms with proximal necks (“landing zones”) as short as 10 mm. This stent graft has been used internationally for more than 12 years and, during that time, implanted in more than 45,000 patients. Addressing a condition of FDA approval, VITALITY will involve a total of 260 subjects and up to 30 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 prevent it. The study design incorporates the test group of 166 patients from the earlier study that supported the device’s FDA approval in 2008, as well as an additional 94 new subjects to be prospectively enrolled. All subjects will be followed for five years. Dr. Luis Sanchez of Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis has been chosen as VITALITY’S principal investigator.