The latest registry update includes 3-year follow-up data on 00 patients enrolled in the global registry, with data showing a 98% rate of freedom from aneurysm-related death and 90.7% freedom from revision subsequent endovascular procedures following implantation of the Endurant II stent graft.
Graft-related complications were reportedly low with a 0% rate of device migration and 1.5% rate of Type I/III leakage. The results mimic real-world use, Medtronic said, as about 18% of the patients treated had anatomical characteristics that don’t fit within the device’s standard instructions for use.
The ENGAGE registry also features a 10.5% female population, the largest female cohort in any endovascular aortic repair clinical study, Medtronic said.
The Endurant II claims about half of the market for endovascular abdominal aortic aneurysm repairs worldwide, according to a Medtronic statement, and the ENGAGE registry has enrolled more than 1,200 patients so far from 79 sites spread across 6 continents since the device in 2008 won CE Mark approval in the European Union. The registry is scheduled to conduct 5 years of follow up on all its patients, making it what Medtronic called the "most robust post-market registry ever initiated for a newer generation stent graft."
The Endurant II stent graft system takes an internal approach to infrarenal abdominal aortic or aorto-iliac aneurysms, permanently providing an alternative route for blood flow. The device is comprised of the stent graft and a pre-loaded, disposable delivery system. The Endurant II is self-expanding upon deployment and conforms to patient vasculature to provide a seal to prevent leakage.