Medtronic (NYSE:MDT) today announced positive results from its 10-year post-market registry for the Endurant stent graft.
The Endurant stent graft system offers Endovascular aneurysm repair (EVAR) to treat patients with abdominal aortic aneurysm (AAA). Medtronic posted the real-world data at the 2023 Charing Cross Symposium in London, marking the completion of the study.
Dr. Hence Verhagen, ENGAGE investigator, called the data “strong and robust evidence” demonstrating long-term durable outcomes. Verhagen serves as chief of vascular surgery at Erasmus University Medical Center in Rotterdam, The Netherlands. He also presented the data in London.
The ENGAGE registry evaluated more than 1,200 patients. Ten-year data included follow-up from approximately 400 of these patients and showed a 94.7% freedom from aneurysm-related mortality. It also demonstrated a 64.1% sac regression (or decreased AAA sac diameter at 10 years.
At the completion of the study, the registry included patients spanning 49 sites in 21 countries. Medtronic initiated the registry less than one year after receiving CE mark approval.
Medtronic said its goal for ENGAGE was to gather real-world patient evidence, including for those with challenging anatomy. The company observed clinical follow-up compliance of 89.7% and imaging compliance of 68.3% at 10 years.
“As Medtronic works to increase access to treatment for patients with Aortic disease, the 10-year results of the ENGAGE registry demonstrate a critical achievement in the commitment we have made to leading the advancement of EVAR,” said Carolyn Sleeth, VP and GM of the Aortic business in Medtronic’s Cardiac and Vascular Group. “These data add to the current evidence showing that the Endurant stent graft system has a decade of proven long-term durable outcomes and allows physicians the opportunity to treat their patients with the most reliable device.”