Gore today announced that the US Food and Drug Administration (FDA) has approved updated labelling for the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis and the Gore Excluder conformable AAA endoprosthesis. The labelling adds real‑world clinical evidence that supports the use of endovascular aneurysm repair (EVAR) devices in appropriately selected patients with ruptured abdominal aortic aneurysm (rAAA).
Gore notes in a press release that this approval includes removal of the prior warning that these devices have not been evaluated in ruptured aneurysms—labelling historically applied across commercially available EVAR devices for ruptured aneurysms.
The company states that the Excluder AAA endoprosthesis and the Excluder conformable AAA endoprosthesis are widely used for EVAR and supported by long‑term clinical outcomes and ongoing regulatory approvals. In addition to evidence from the International Consortium of Vascular Registries that is included in the labelling update, real-world data from the Global Registry for Endovascular Aortic Treatment (GREAT) and the Gore Together Aortic Registry (TOGETHER) further demonstrate evidence in ruptured aneurysms:
- 100% procedural technical success
- 0–0.9% procedural all-cause mortality
- 0–5.3% lesion-related mortality through two years
- 11.1–15.9% device-related reinterventions
“In emergent rAAA, access to proven devices with clear labelling is critical,” said Alyssa Pyun (University of Southern California, Los Angeles, USA). “This update reflects growing clinical experience with these devices and supports physicians caring for patients with complex and urgent aortic disease.”
