ARTICLE SUMMARY:
FDA approval of a labeling change that will allow Medtronic and Gore to help physicians learn to use stent grafts to treat ruptured abdominal aortic aneurysms. Excerpted from our recent feature article “Medtronic and Gore Break Through EVAR-Labeling Logjam.”
Stent-grafts designed for endovascular aortic repair (EVAR) are deployed inside the native vessel to exclude the aneurysm from the aortic blood flow to prevent it from expanding or rupturing. EVAR for abdominal aortic aneurysms (AAA) began in the late 1980s as a less-invasive alternative to surgery and stent grafts designed specifically for AAA reached the market in the late ’90s. Because EVAR is less invasive than surgery, it has overtaken surgical repair as the preferred option for AAA and now accounts for over 80% of AAA repairs in the US.
Most of those EVAR procedures are planned or elective, but the AAA patients in most dire need of repair are those whose AAA has already ruptured. The overall mortality rate for a ruptured AAA is around 80% and about 30% for patients who reach an operating room. Many of those patients cannot withstand surgery.
Until late last year, the FDA-approved labeling for EVAR devices included a warning about the lack of safety and effectiveness data supporting EVAR in the emergency treatment of aneurysms, so the stent-graft manufacturers could not market devices for that indication or, critically, help physicians learn how to implant their devices in patients with a ruptured AAA.
In September 2025 the US FDA expanded the approved labeling for Medtronic’s Endurant stent graft system to include ruptured AAAs. Specifically, FDA removed a specific warning about the lack of safety and effectiveness data supporting emergency treatment of ruptured aneurysms, which had been part of Endurant’s labeling since it was first approved in 2010. Endurant is also the first EVAR device to earn a CE mark for the ruptured AAA indication, the company announced on September 3.
In May 2026, the FDA approved a similar change to the labeling of Gore’s Excluder AAA and Excluder Conformable AAA endoprosthesis systems. Excluder has been on the market since 2002.
The labeling change comes over 26 years since FDA first approved two stent grafts for endovascular aortic repair with the 1999 approvals of Medtronic’s AneuRx and Guidant’s Ancure. The approved labeling for those devices previously warned that the safety and effectiveness of the devices in the treatment of ruptured AAAs was not established, but many centers used EVAR for that indication in the early 2000s.
Although EVAR for ruptured AAA has already been the standard of care for almost a decade, the FDA label change is important to Gore and Medtronic. The warning on the FDA-approved labeling constrained whatthe companies could say about their devices. The new label gives them the ability to provide education and clinical training on this indication.