Medtronic, Inc., today 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 U.S. patient population,” said vascular surgeon Dr. George Pliagas, who led the team at St. Mary’s Medical Center in Knoxville, Tenn., 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 U.S. 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. The Talent Abdominal 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 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 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, Mo., has been chosen as VITALITY’S principal investigator.
An aortic aneurysm is a dangerous bulge or weakening in the body’s main artery that can rupture with fatal consequences if left untreated. According to the Society for Vascular Surgery, abdominal aortic aneurysms – the most common type – are responsible for approximately 15,000 U.S. deaths annually; it is estimated that more than one million people are living with undiagnosed aortic aneurysms, and that 95 percent of these could be successfully treated if detected before rupture.
EVAR involves the navigation of a stent graft – a fabric tube reinforced with a metal mesh – via the body’s arteries to the aorta. The stent graft is then deployed, allowing blood flow through the aorta while reducing pressure on the aneurysm and the risk of rupture.
A pioneer of EVAR, Medtronic has been an innovator and leader in the stent graft industry since the 1990s. Its history includes more than 150,000 patients treated with stent grafts. Medtronic offers the broadest portfolio of aortic stent grafts. The AneuRx AAAdvantage® and Talent Abdominal Stent Grafts with the Xcelerant® Hydro Delivery System and the Talent Thoracic Stent Graft with the Xcelerant Delivery System are commercially available in the United States. The Valiant® Thoracic Stent Graft and the Endurant® Stent Graft Systems are commercially available only outside the United States and are currently under clinical investigation in the U.S. The Reliant® Stent Graft Balloon Catheter is commercially available worldwide.