Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Medtronic, a medical technology company, has 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.
Subscribe to our email newsletter
According to the company, the Talent abdominal stent graft expands the applicability of endovascular aneurysm repair, 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 10mm, the company claims.
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. Vitality will gather clinically relevant data on the safety and efficacy of the Talent abdominal stent graft in a real-world US patient population.