Medtronic has received CE-mark approval for the Endurant stent graft system to remove a ruptured abdominal aortic aneurysm (rAAA) treatment warning, the company shared in a press release this week. The labelling update follows the US Food and Drug Administration (FDA) labelling approval received in October 2025.
“When a patient presents with a ruptured abdominal aortic aneurysm, every minute counts,” shares Felice Pecoraro (University of Palermo and Universitaria Policlinico P Giaccone, Palermo, Italy). “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 [instructions for use] is a meaningful step forward.”
“The significance of this approval extends beyond the individual procedure. By aligning labelling with the clinical evidence and current practice, hospitals and vascular teams can build more standardised protocols, training programmes, 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,” says Konstantinos Spanos (University Hospital of Larissa, University of Thessaly, Larissa, Greece).
Medtronic shares that Endurant, which is designed to treat AAAs using endovascular aneurysm repair (EVAR), is backed by “robust” clinical evidence from the ENGAGE 10-year global registry to demonstrate safe and effective use. The company desribes the Endurant as the “first and only” EVAR system with a decade of global registry outcomes.
