Medtronic, Inc. has filed a Pre-Market Approval (PMA) application with the FDA for the company’s new Talent™ Abdominal Stent Graft System. This endovascular device is similarly designed, and is in the same family, with previously reported Talent™ Thoracic Stent Graft System for descending thoracic aneurysms.
The Talent Abdominal Stent Graft is designed to offer broad patient applicability and ease of use, and a history of established clinical performance with more than 40,000 implants worldwide. The results of the clinical trial demonstrated that the study met its primary 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 percent. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, they experienced lower rates of death, myocardial infarction, respiratory failure, paraplegia, and blood loss compared with subjects treated with open surgery at 12 months. There were no aneurysm ruptures and no conversions to open surgery in the Talent Abdominal Stent Graft group up to 12 months after device implantation.
“As part of the FDA’s modular review process, we have submitted the final module — a comprehensive clinical data set for the Talent Abdominal Stent Graft PMA application,” said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. “The Talent Abdominal System will expand treatment options for patients with abdominal aortic aneurysms and provide a strong complement to our market-leading AneuRx® AAAdvantage Stent Graft.”