Study of Endurant AAA stent graft meets endpoint in aneurysm treatment-Medtronic

The Endurant AAA stent graft system from Medtronic maintained durable, consistent and proven outcomes through five years of follow-up in the company's U.S. clinical study of the implantable medical device, according to new clinical data. The prospective, multi-center, non-randomized bifurcated arm of the study enrolled 150 patients at 26 US medical centers, met its primary safety and effectiveness endpoints and contributed to the device's approval by the FDA in December 2010.

The study's primary safety and effectiveness endpoints were major adverse events (MAE) at 30 days and successful aneurysm treatment at 12 months, respectively. Five year follow-up was also conducted. Significantly for clinical practice, the study included patients with "landing zones," or healthy aortic neck lengths, as short as 10 mm, whereas most other trials of aortic stent grafts have required neck lengths of at least 15 mm. Highlights of the findings include 99.2 percent freedom from aneurysm related mortality and 89.0 percent freedom from secondary endovascular interventions through five years.

In addition, an independent imaging core laboratory reported 95.2 percent of the patients' aneurysm sacs remained stable or decreased in diameter by more than 5 mm at five years. Indicative of excellent exclusion of the aneurysm, there were no (0.0%) Type I or III endoleaks at five years and no migrations occurred through the five-year follow-up. Results were presented at the Society for Vascular Surgery's Vascular Annual Meeting.