A Medical Device Daily
Medtronic (Minneapolis) reported filing the final module of its premarket application with FDA for its Talent abdominal stent graft system, a minimally-invasive device that treats dangerous bulges in the aorta, a large artery that can rupture without warning.
Medtronic said that the Talent has a history of established clinical performance with more than 40,000 implants worldwide.
A clinical trial demonstrated that the device met its safety endpoint of superiority in freedom from major adverse events at 30 days, and the aneurysm-related mortality rate at 12 months was 1.8%. The patients receiving the Talent were older and had higher-than-baseline co-morbidities, they had lower rates of death, myocardial infarction, respiratory failure, paraplegia, and blood loss compared with subjects treated with open surgery at 12 months, according to the company. There were no aneurysm ruptures and no conversions to open surgery in the Talent group up to 12 months after implantation.
The final module is “a comprehensive clinical data set,” said Katie Szyman, VP and general manager of Medtronic’s endovascular innovations business. She said that Talent “will expand treatment options for patients with abdominal aortic aneurysms and provide a strong complement to our market-leading AneuRx AAAdvantage stent graft.”