New results from global registry for Endurant II/IIs stent graft system in abdominal aortic aneurysm- Medtronic

Medtronic has announced data supporting the strength and durability of the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients. The results are based upon new sub-analyses of Medtronic's ENGAGE Global Registry, which has enrolled more than 1,200 patients at 79 sites across six continents. With 10-year follow-up planned for all patients, ENGAGE represents the most robust post-market registry ever initiated in the study of endovascular aortic repair (EVAR).

In a finding based on the full registry cohort (n=1263), patients were free from Type Ia endoleaks for up to four years, with rates of 97.8 percent (one year), 97.3 percent (two years), 96.7 percent (three years), and 96 percent (four years). Similar results were seen in sub-analyses of both standard and complex patients at all time points.

A second sub-analyses showed that Endurant achieves positive results in patients with various hostile neck types followed up to four years. At four years these mid-term outcomes, such as aneurysm related mortality, rupture and conversion to open surgical repair, offer clinical insight into the treatment of AAA neck anatomies that is relevant and applicable to current clinical practice and real-world settings. The data was presented during the 43rd Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium) in New York.

Comment: Since the original Endurant system received CE Mark approval in June 2008, the ENGAGE registry has enrolled more than 1,200 patients. The Endurant stent graft system has been approved in the U.S. since December 2010.