Two-Year Data Presented for Medtronic's Endurant AAA Stent Graft

November 19, 2012—Medtronic, Inc. (Minneapolis, MN) announced that its Endurant abdominal aortic aneurysm (AAA) stent graft system continued to show robust results in midterm follow-up data. Findings from two clinical evaluations with 2 years of patient follow-up—the United States investigational device exemption (IDE) study and the international ENGAGE registry—were presented by ENGAGE investigator Dittmar Bockler, MD, PhD, at the VEITH Symposium in New York City. Dr. Bockler is from the University Hospital of Heidelberg in Germany.

The IDE study of the Endurant system enrolled 150 patients at 26 centers in the United States and led to the device's approval by the US Food and Drug Administration in December 2010. The international ENGAGE registry has enrolled more than 1,200 patients at more than 80 sites across six continents since the Endurant system received CE mark approval in June 2008.

“It's reaffirming to see that the 2-year data from the international ENGAGE registry and the United States IDE study are similar to what we saw at 1 year, which indicates that the Endurant AAA stent graft continues to perform well in a variety of geographic locations and patient anatomies,” commented Dr. Bockler in the company's press release. “The Endurant system sets a new standard in clinical outcomes for aortic stent grafts with unprecedented breadth, depth, quality, and consistency of results.”

According to Medtronic, 2-year results on 500 patients from the international ENGAGE registry showed that more than 98% (490 patients) were free from aneurysm-related mortality—defined as death from rupture or from any procedure intended to treat the aneurysm—through 2 years of postprocedure follow-up. The Type I/III endoleak rate was low (1.1%) for this real-world patient population, with more than half (56%) of the aneurysm diameters among these 500 patients showing a reduction in size of 5 mm or more.

Similar safety and efficacy were demonstrated in the 2-year results on all 150 patients from the United States IDE study that showed 100% freedom from aneurysm-related mortality. Additionally, the type I/III endoleak rate was low (0.8%), with more than three-fifths (62%) of the aneurysm diameters showing a reduction in size of 5 mm or more, advised the company.