Medtronic’s Endurant abdominal aortic aneurysm (AAA) stent graft system for endovascular aneurysm repair (EVAR) is associated with strong 10-year outcomes, according to new real-world data presented at the 2023 Charing Cross Symposium in London. This update represents the end of the ENGAGE study, which first launched back in 2009.
ENGAGE examined the safety and effectiveness of the Endurant system in more than 1,200 real-world patients. Researchers evaluated follow-up data from approximately 400 of those patients, noting that 10-year freedom from aneurysm-related mortality was seen in 94.7% of cases and 10-year sac regression was seen in 64.1% of cases.
ENGAGE investigator Hence Verhagen, MD, chief of vascular surgery at Erasmus University Medical Center in the Netherlands, presented the data.
“There is now strong and robust evidence that patients treated with the Endurant stent graft system are reaching long-term durable outcomes,” Verhagen said in a prepared statement. “We can continue to offer the Endurant stent graft system to any of our patients suitable for endovascular repair as the only graft with global, robust, real-world clinical data to 10 years with consistent sac regression and low aneurysm-related mortality.”
“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,” added Carolyn Sleeth, vice president and general manager of the aortic business at Medtronic. “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.”
According to Medtronic, the Endurant system has already been used to treat more than 500,000 patients around the world.
In the United States, it is approved for patients with AAA proximal neck length of ≥10 mm and ≤60° infra-renal angulation.
Outside of the United States, the device is approved for patients with AAA proximal neck lengths of ≥10 mm, ≤60° infra-renal angulation and ≤45° supra-renal angulation. It is also approved for patients with AAA proximal neck lengths of ≥15mm, ≤75° infra-renal angulation and ≤60° supra-renal angulation.
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