Advertisement
Advertisement
September 4, 2026
Medtronic’s Endurant Stent Graft System Receives Updated Ruptured AAA Labeling in Europe
KEY TAKEAWAYS
- Medtronic received CE Mark approval to remove the ruptured AAA treatment warning from the Endurant stent graft system labeling.
- The European update comes after an FDA labeling change for the Endurant system in October 2025.
- Physicians stated the revised labeling may support more standardized protocols, training, and treatment pathways for urgent aortic care.
September 4, 2026—Medtronic announced it has received CE Mark approval for the Endurant stent graft system to remove the ruptured abdominal aortic aneurysms (rAAA) treatment warning.
According to the company, the European labeling update comes after the FDA labeling approval in the United States was received in October 2025 and extends the Endurant rAAA labeling to support expanded training and educational opportunities in Europe.
“When a patient presents with an rAAA, every minute counts,” commented Felice Pecoraro, MD, in the company’s press 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 indications for use is a meaningful step forward.” Dr. Pecoraro is Professor of Vascular Surgery at University of Palermo and Director of the Vascular Surgery Unit at A.O. Universitaria Policlinico P. Giaccone in Palermo, Italy.
Konstantinos Spanos, MD, added, “The significance of this approval extends beyond the individual procedure. 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. 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.” Dr. Spanos is Associate Professor of Vascular Surgery, University Hospital of Larissa, University of Thessaly in Volos, Greece.
Advertisement
Advertisement