FDA OKs Gore’s Excluder Endoprostheses for Ruptured AAA

Gore Medical has received approved, updated labeling from the U.S. Food and Drug Administration (FDA) for its Excluder AAA (abdominal aortic aneurysm) endoprosthesis and Excluder conformable AAA endoprosthesis.

The approval was based on real-world evidence that supports use of EVAR (endovascular aneurysm repair) devices in appropriate patients with ruptured abdominal aortic aneurysm (rAAA). The approval also removes the prior warning that the devices weren’t evaluated in ruptured aneurysms.

The Excluder endoprostheses are backed by evidence from the International Consortium of Vascular Registries that’s included in the labeling update. Real-world data from the Global Registry for Endovascular Aortic Treatment (GREAT) and the Gore Together Aortic Registry (TOGETHER) further demonstrated evidence in ruptured aneurysms, the company said.

Among the data is 100% procedural technical success, 0-0.9% procedural all-cause mortality, 0-5.3% lesion-related mortality through two years, and 11.1-15.9% device-related reinterventions.

Last month, Gore earned a CE mark for its Viabahn Fortegra venous stent, which is indicated to treat symptomatic inferior vena cava (IVC) and iliofemoral venous outflow obstruction.

Comments from Gore Medical and clinicians

Jason Belzer, Gore Americas business leader: “This FDA labeling update is an important step forward for physicians treating ruptured abdominal aortic aneurysms—one of the most challenging conditions in vascular care. We are proud to see the EXCLUDER AAA Endoprosthesis and the EXCLUDER Conformable AAA Endoprosthesis labeling change reflect the growing clinical evidence and support confident decision-making for physicians treating patients in urgent, life threatening situations.”

Alyssa Pyun, MD, division of vascular surgery and endovascular therapy, University of Southern California: “In emergent rAAA, access to proven devices with clear labeling is critical. This update reflects growing clinical experience with these devices and supports physicians caring for patients with complex and urgent aortic disease.