Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device.
Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 Charing Cross Symposium in London this week.
“Medtronic aims to increase access to treatment for patients with aortic disease. This goal has been reinforced by our commitment to developing robust clinical programs – such as the Engage registry – that help clinicians identify durable treatment options. In fact, we are leveraging our strong Endurant stent graft data for a pilot risk-share program in the U.S. that has been designed to help decrease customer costs associated with secondary EVAR interventions,” Medtronic aortic biz GM Daveen Chopra said in a press release.
Data was collected from more than 1,200 patients and included imaging follow-ups from approximately 500 patients, the Fridley, Minn.-based company said.
Results indicated a 97.8% freedom form aneurysm-related mortality for patients treated with the device, and an 89.4% rate of stable or decreasing diameter AAA sac size at 5-years. Data also indicated an 84.3% rate of freedom from secondary endovascular procedures, Medtronic said.
“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,” primary study investigator Dr. Philippe Cuypers of the Catharina Hospital in Eindhoven, The Netherlands said in a prepared release.
Last December, Medtronic said it won an expanded CE Mark indication in the European Union for its Endurant II/IIs stent graft for treating abdominal aortic aneurysms.