Medtronic has reported positive findings from the ongoing global endurant stent graft natural selection global postmarket (ENGAGE) registry of patients treated with the company’s Endurant II AAA device.
The Endurant stent graft is a self-expanding nitinol device designed for the endovascular treatment of abdominal aortic aneurysms.
The study enrolled more than 1,200 patients at 79 sites across six continents since 2008, after receiving CE Mark approval for Endurant system.
With five-year follow-up planned for all patients, the ENGAGE registry represents the most robust post-market registry ever initiated for a new-generation stent graft.
The latest registry update includes three-year follow-up data on 500 patients enrolled in the global ENGAGE registry, with data showing a 98.4% 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 whole body migration and a 1.5% rate of Type I/III endoleak.
Positive results were also presented for the full 1,263 patient cohort evaluated at two years of follow-up study.
A rigorous monitoring protocol has resulted in follow-up compliance of more than 90% in the ENGAGE registry, which is unprecedented for any registry and improves the reliability of the data.
University Hospital of Heidelberg in Germany ENGAGE investigator Dr Dittmar Böckler presented the data.
"The size and scope of the ENGAGE registry distinguish Medtronic among stent graft makers as a committed partner in building the clinical evidence portfolio for EVAR worldwide," he said.
"It is especially compelling to see that at three years, the Endurant system has maintained durable, long-term outcomes in treating abdominal aortic aneurysms in a real-world cohort that represents the types of challenging anatomies physicians encounter in daily clinical practice."
The Endurant system is approved for use in patients with neck lengths of 10mm or greater.
Additional analysis of the patient cohort revealed that 18% of the patients treated had anatomical characteristics that do not fit within the device’s standard instructions for use.
The ENGAGE registry also features 10.5% of female patients, which is the largest female cohort in any endovascular aortic repair clinical study, while 16% of patients had symptomatic abdominal aortic aneurysms.
The Endurant II AAA stent graft system sets the standard for EVAR, with proven performance in more than 100,000 patients worldwide.
With a comprehensive clinical programme that includes nearly 2,000 patients, Medtronic is continuing to grow the body of clinical evidence for the Endurant II system in both controlled settings and real-world practice.
The company presented the three-year clinical data from global ENGAGE registry at the VEITHsymposium in New York City.
According to GlobalData estimates, the US abdominal aortic stent grafts market was valued at $553m in 2012 and is expected to grow at a CAGR of 3.2% to reach $690m by 2019.
Image: An Endurant AAA stent graft. Photo: courtesy of Medtronic, Inc.