Medtronic stent graft system secures key labeling update

Michael Walter | September 04, 2026 | Cardiovascular Business | Vascular & Endovascular

Medtronic has received CE mark approval for a major change to the labeling of its Endurant stent graft system. The device, which has been used by clinicians for many years now to treat abdominal aortic aneurysms (AAAs), no longer needs to include a warning about the device not being evaluated for the treatment of ruptured AAAs in its instructions for use (IFU).

This is expected to boost clinician confidence and help more patients with ruptured AAAs receive endovascular aneurysm repair (EVAR) when needed.

“This milestone represents an important advancement in helping care teams act with clarity and decisiveness when minutes matter most,” Nicolas Berney, the vice president of Medtronic’s cardiovascular surgery division for Western Europe, said in a prepared statement. “As we bring this labeling update to Europe, we remain committed to pairing strong clinical evidence with the education and support care teams need when making time-critical treatment decisions.”

“When a patient presents with a ruptured abdominal aortic aneurysm, every minute counts,” added Felice Pecoraro, MD, a professor of vascular surgery at the University of Palermo and director of the vascular surgery unit at A.O. Universitaria Policlinico P. Giaccone. “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.”

Medtronic received a similar update to its IFU from the U.S. Food and Drug Administration (FDA) in October 2025. It was the first time such an update was approved for any EVAR system in the United States.

In July 2026, the FDA approved the same update for Gore Medical’s Gore Excluder AAA Endoprosthesis and Gore Excluder Comfortable AAA Endoprosthesis.