Five-Year Results Presented for Medtronic's Endurant IDE Study at SVS Meeting

June 20, 2015—Five-year results from the US IDE study for Medtronic’s Endurant abdominal aortic aneurysm (AAA) stent graft system were presented at the late-breaking clinical trial session at the Society for Vascular Surgery’s Vascular Annual Meeting in Chicago, Illinois. The new data, presented by Michael J. Singh, MD, Associate Professor of Surgery at University of Pittsburgh Medical Center, supports the device’s long-term durability and demonstrated consistent outcomes for endovascular repair of AAA (EVAR).

The prospective, multicenter, nonrandomized bifurcated arm of the study enrolled 150 patients at 26 medical centers in the United States and met its primary safety and effectiveness endpoints and contributed to the device’s US Food and Drug Administration approval in December 2010. The study’s primary safety and effectiveness endpoints were major adverse events at 30 days and successful aneurysm treatment at 12 months, respectively. The study, aiming to include real-world anatomy, enrolled patients with landing zones as short as 10 mm, whereas most trials of aortic stent grafts have required neck lengths of at least 15 mm.

Highlights of the findings included a 99.2% rate of freedom from aneurysm-related mortality and 89% percent freedom from secondary endovascular interventions through 5 years. In addition, an independent imaging core laboratory reported 95.2% of the patients’ aneurysm sacs remained stable or decreased in diameter by more than 5 mm at 5 years. There were no (0.0%) type I or III endoleaks at 5 years, and no migrations occurred through the 5-year follow-up.

“The five-year results from this study reinforce the long-term durability and consistency of the clinical outcomes that vascular specialists around the world have experienced with the Endurant AAA stent graft system,” Dr. Singh said in the company’s press release. “These results add to the growing body of evidence in support of the Endurant platform for endovascular AAA repair.”

The device also achieved excellent procedural performance in the study, with successful delivery and deployment in 99.3% of patients and a mean procedure time of 101.5 minutes.

“By delivering durable and consistent outcomes for patients with AAAs, the Endurant AAA stent graft system has the potential to deliver economic value to hospitals as well,” commented Dr. Edward Woo, MD, Director of the MedStar Regional Vascular Program, Chairman of Vascular Surgery at MedStar Washington Hospital Center and Professor of Surgery at Georgetown University, who previously presented on the clinical and economic effectiveness of the Endurant stent graft at Charing Cross 2015. “These financial benefits come from reducing operational costs and readmissions.”