FDA Approves Updated Labeling of Gore Excluder EVAR Devices for Ruptured AAAs

July 7, 2026—Gore & Associates announced that the FDA approved updated labeling for the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis and Gore Excluder Conformable AAA endoprosthesis, adding real-world clinical evidence that supports the use of endovascular aneurysm repair (EVAR) devices in appropriately selected patients with ruptured AAAs (rAAAs).

According to the company, the labeling approval includes removal of the warning that these devices have not been evaluated in ruptured aneurysms. That warning label historically is applied across commercially available EVAR devices for ruptured aneurysms, noted Gore.

The company noted that the Excluder and Excluder Conformable AAA endoprosthesis devices, which are widely used for EVAR, are supported by long-term clinical outcomes and ongoing regulatory approvals.

Gore advised that in addition to evidence from the International Consortium of Vascular Registries that is included in the labeling update, real-world data from the GREAT and TOGETHER registries provided further evidence in ruptured aneurysms. Findings included 100% procedural technical success (TOGETHER); 0% to 0.9% procedural all-cause mortality (GREAT and TOGETHER); 0% to 5.3% lesion-related mortality through 2 years (GREAT and TOGETHER); and 11.1% to 15.9% device-related reinterventions (GREAT), reported the company.

“In emergent rAAA, access to proven devices with clear labeling is critical,” commented Alyssa Pyun, MD, in Gore’s press release. “This update reflects growing clinical experience with these devices and supports physicians caring for patients with complex and urgent aortic disease.” Dr. Pyun is with the Division of Vascular Surgery and Endovascular Therapy at University of Southern California in Los Angeles, California.