Medtronic presented the new data, compiled from a U.S. investigational device exemption study and an international ENGAGE registry of Endurant AAA patients, at the VEITHsymposium in New York this week.
"It’s reaffirming to see that the 2-year data from the international ENGAGE registry and the U.S. 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," ENGAGE investigator Dr. Dittmar Bockler of the University Hospital of Heidelberg in Germany said in prepared remarks. "The Endurant system sets a new standard in clinical outcomes for aortic stent grafts with unprecedented breadth, depth, quality and consistency of results."
Doctors pick the Endurant AAA stent graft system for nearly half of all endovascular abdominal aortic aneurysm repairs worldwide, according to Medtronic.
The pair of studies include more than 1,350 patients from 26 centers in the U.S. and more than 80 worldwide.
Results from the ENGAGE study found that more than 98% of patients were free from aneurysm-related mortality at 2 years following Endurant AAA treatment, and the U.S. IDE study showed 100% freedom at 2 years. Type I/III leakage was low in both studies (1.1% for ENGAGE, 0.8% for the IDE study), and aneurysm diameter reduction was significant (56% and 62%, respectively).
Earlier this year Medtronic touted CE Mark approval in the European Union for its Endurant II stent graft. The product line’s predecessor, the Endurant, won PMA in December 2010.