The Minnesota-run medtech giant received a similar FDA labeling change in late 2025.
A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal bleeding and the need for immediate emergency surgical intervention. According to the Medtronic news release out today, half the people with a ruptured AAA die before they even reach the hospital; the overall mortality rate is 80–90%. Now, Endurant is more likely to provide an option in these emergency cases in Europe.
The updated Endurant rAAA labeling supports expanded training and educational opportunities in the EU.
“When a patient presents with a ruptured abdominal aortic aneurysm, every minute counts,” Dr. Felice Pecoraro, professor of vascular surgery at the University of Palermo and director of the vascular surgery unit at A.O. Universitaria Policlinico P. Giaccone, said in the news release. “For physicians, this update provides greater clarity and supports confident decision-making while evaluating treatment options for their patients. In an emergency where time is critical, having this change to the IFU is a meaningful step forward.”
Said Nicolas Berney, Medtronic VP for Western Europe CardioVascular Surgery: “This milestone represents an important advancement in helping care teams act with clarity and decisiveness when minutes matter most.”
The significance of the CE mark goes beyond the individual procedure, according to Dr. Konstantinos Spanos, associate professor of vascular surgery at University Hospital of Larissa, part of the University of Thessaly in Greece.
“By aligning labeling with the clinical evidence and current practice, hospitals and vascular teams can build more standardized protocols, training programs, and treatment pathways around a platform they know well,” Spanos said. “This can also help expand access to minimally invasive care while supporting more consistent delivery of urgent aortic care for patients facing this life-threatening condition.
Medtronic says the Endurant stent graft system has treated more than half a million patients worldwide for over a decade.
