Medtronic’s Endurant AAA Stent Graft Studied at 10 Years in Completed ENGAGE OUS Registry

April 26, 2023—Medtronic announced data demonstrating the long-term durability of its Endurant abdominal aortic aneurysm stent graft system in a real-world setting. The 10-year data from ENGAGE were presented at CX 2023, the Charing Cross International Symposium held April 25-27 in London, United Kingdom. This 10-year milestone marks the completion of the study.

According to Medtronic, the ENGAGE registry evaluated > 1,200 patients. The 10-year data included follow-up from approximately 400 of these patients and showed a 94.7% freedom from aneurysm-related mortality and 64.1% sac regression at 10 years.

ENGAGE investigator Hence Verhagen, MD, Professor and Chief of Vascular Surgery, Erasmus University Medical Center in Rotterdam, The Netherlands, presented the data at CX 2023.

“Today with the release of the ENGAGE 10-year data, we have achieved a major milestone in endovascular aneurysm repair therapy,” commented Prof. Verhagen in Medtronic’s press release. “There is now strong and robust evidence that patients treated with the Endurant stent graft system are reaching long-term durable outcomes. We can continue to offer the Endurant stent graft system to any of our patients suitable for endovascular repair as the only graft with global, robust, real-world clinical data to 10 years with consistent sac regression and low aneurysm-related mortality.”

The company stated that the goal of ENGAGE was to gather evidence in a real-world patient population, including patients with challenging anatomy who have historically been difficult to treat and are associated with limited eligibility for endovascular repair and higher rates of secondary interventions. A thorough monitoring protocol resulted in a clinical follow-up compliance of 89.7% and imaging compliance of 68.3% at 10 years.

At its completion, the ENGAGE registry included patients from 49 sites in 21 countries. The ENGAGE registry was initiated less than 1 year after CE Mark approval in July 2008, noted the company.