Five-Year Data From the ENGAGE Postmarket Registry Presented for Medtronic's Endurant II EVAR System

April 26, 2017—Medtronic announced that 5-year data from the ENGAGE global registry were presented by Philippe Cuypers, MD, at the 2017 Charing Cross Symposium in London, United Kingdom. The data indicate that the company's Endurant II stent graft system for the endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) continues to demonstrate long-term durability and consistent outcomes in a real-world setting.

According to Medtronic, the ENGAGE registry evaluated more than 1,200 patients. The 5-year data, which included follow-up imaging from approximately 500 of these patients, showed a 97.8% freedom from aneurysm-related mortality (ARM) and 89.4% stable or decrease in AAA sac diameter. The data also demonstrated an 84.3% freedom from secondary endovascular procedures.

In the company's press release, Dr. Cuypers commented, "Out to 5 years, the ENGAGE data showed low ARM and secondary procedure rates. This further demonstrates both the benefit of the technique used with Endurant as well as the durability of the graft itself. The clinical rigor and scope of the ENGAGE registry has made it a valuable data set that represents the types of challenging anatomies physicians encounter in daily clinical practice.”

The postmarket ENGAGE registry enrolled patients at 79 sites in 30 countries. The ENGAGE registry was initiated < 1 year after CE Mark approval and has clinical follow-up out to 10 years. The goal of ENGAGE remains 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 EVAR and higher rates of secondary interventions. A rigorous monitoring protocol has resulted in a clinical follow-up compliance rate of > 90% and imaging compliance of > 75% at 5 years, noted Medtronic. 

Also at the Charing Cross Symposium, the Endurant stent graft system was featured in a presentation showcasing how the ENGAGE data are being used to inform clinicians' treatment decisions following EVAR procedures. Peter Holt, MD, presented the design of the LEAR (Long-term Estimation of Aortic Risk) analysis, which aims to reduce long-term aortic risk using a modified clinical surveillance program that more accurately portrays reintervention risk.

Prof. Hence Verhagen, MD, presented “Safety Considerations with Hostile Neck 10–15 mm,” which showed Endurant's durable results across a range of patient anatomies, including patients with more hostile aortic necks.

Medtronic's Endurant II/IIs stent system received CE Mark approval in June 2008 and US Food and Drug Administration approval in December 2010. The Endurant stent graft system is approved outside of the United States for use in patients with AAA neck lengths ≥ 10 mm and ≤ 60° infrarenal angulation and ≥ 15 mm with ≤ 75° infrarenal angulation. In the United States, the Endurant stent graft system is indicated for necks ≥ 10 mm and ≤ 60° infrarenal angulation, the company noted.