/Press Release

FDA APPROVES LABELING UPDATE REFLECTING EVIDENCE IN RUPTURED AAA FOR GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

FLAGSTAFF, Arizona (July 7, 2026)—W. L. Gore & Associates’ medical business (“Gore”) announced today that the U.S. Food and Drug Administration has approved updated labeling for the GORE® EXCLUDER® AAA Endoprosthesis and the GORE® EXCLUDER® Conformable AAA Endoprosthesis, adding real‑world clinical evidence that supports the use of EVAR devices in appropriately selected patients with ruptured abdominal aortic aneurysm (rAAA). This approval includes removal of the prior warning that these devices have not been evaluated in ruptured aneurysms—labeling historically applied across commercially available EVAR devices for ruptured aneurysms.

“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,” said Jason Belzer, Gore Americas Business Leader. “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.”

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 labeling update*, real-world data from the Global Registry for Endovascular Aortic Treatment (GREAT)1 and the Gore Together Aortic Registry (TOGETHER)2 further demonstrate evidence in ruptured aneurysms**:

  • 100% procedural technical success2
  • 0%-0.9% procedural all-cause mortality1,2
  • 0%-5.3% lesion-related mortality through 2 years1,2  
  • 11.1-15.9% device-related reinterventions1

“In emergent rAAA, access to proven devices with clear labeling is critical,” said Alyssa Pyun, MD, Division of Vascular Surgery and Endovascular Therapy at University of Southern California. “This update reflects growing clinical experience with these devices and supports physicians caring for patients with complex and urgent aortic disease.”

For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU). 

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of 50 years, Gore builds on its legacy of improving patient outcomes through research, education, and quality initiatives. Product performance, ease of use, and quality of service provide sustainable cost savings for physicians, hospitals, and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. goremedical.com

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments—from outer space to the world’s highest peaks to the inner workings of the human body. With approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5.3 billion. gore.com

*    The Gore device reviewed in the ICVR data collection was the EXCLUDER® AAA Endoprosthesis. This device and the EXCLUDER® Conformable AAA Endoprosthesis have the same intended use, share common design elements, and have demonstrated similarities of performance within a traditional EVAR population. See IFU for additional details.

**  Due to the emergent nature of ruptures, all enrollment of rupture patients in real-world registries occurs post-procedurally.

  1. Data on file. Global Registry for Endovascular Aortic Treatment (GREAT). ClinicalTrials.gov identifier: NCT01658787. August 7, 2012. Updated February 9, 2026. Accessed May 19, 2026. https://clinicaltrials.gov/study/NCT01658787
     
  2. Data on file. Endovascular AAA intervention using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis. ClinicalTrials.gov identifier: NCT06218875. January 23, 2024. Updated February 5, 2026. Accessed May 19, 2026. https://clinicaltrials.gov/study/NCT06218875

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