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gore excluder aaa endoprosthesis
W.L. Gore & Associates
Summary: The Gore Excluder AAA Endoprosthesis is a device used for endovascular aneurysm repair. It is primarily used to treat infrarenal aortic aneurysms. Key evidence highlights its long-term performance and safety profile.
FDA Clearance Information
Pathway PMA
Number P020004 ↗
Decision Date September 21, 2006
Product Code MIH
Device Class Class 3
Evidence 40 studies
The Gore Excluder AAA Endoprosthesis was cleared by the FDA via the PMA pathway on September 21, 2006. It is manufactured by W.L. Gore & Associates and is classified as a Class 3 medical device.
What It Is
The Gore Excluder AAA Endoprosthesis is an endovascular stent graft designed to treat abdominal aortic aneurysms. It functions by excluding the aneurysm from blood flow, thereby reducing the risk of rupture. It is intended for use in patients with infrarenal aortic aneurysms.
Clinical Applications
This device is commonly used in the endovascular repair of abdominal aortic aneurysms, particularly in patients who are at high risk for open surgical repair. It is suitable for patients with specific anatomical criteria that align with the device's instructions for use.
Evidence Summary
The available literature includes 14 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2022 to 2026, providing a comprehensive overview of the device's performance.
Reported Outcomes
Published studies report that the Gore Excluder AAA Endoprosthesis demonstrates favorable long-term outcomes in terms of aneurysm exclusion and patient survival. The device has shown efficacy in reducing aneurysm-related mortality and maintaining patency over extended follow-up periods.
Safety Profile
Reported complications include inflammatory responses and potential for serious adverse events, particularly in older patients. Some studies noted the occurrence of inflammatory aneurysms related to elevated serum levels of Immunoglobulin G4 post-procedure.
Evidence Limitations
Evidence gaps include a need for more diverse patient populations and longer follow-up periods to better understand the device's performance across different demographics. Further research is needed to explore the relationship between inflammatory responses and the device.
Linked Studies (20)
PubMed • 2026
Long Term Real World Performance of the Gore Excluder AAA Endoprosthesis Featuring the C3 Delivery System: Ten Year Results from the European C3 Module of the GREAT Registry.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Mid-Term Outcomes of EVAR in Hostile Neck Anatomy: Impact of Graft Adaptability on Type III Endoleak, Aortic Remodeling, and Distal Sealing.
Journal of clinical medicine
View Source → PubMed • 2025
Conformable Endovascular Aneurysm Repair (EVAR) Stability in Hostile Neck Abdominal Aortic Aneurysms: A Single-Center Experience.
Cureus
View Source → PubMed • 2025
Early results from the pivotal trial substudy of the GORE EXCLUDER conformable endoprosthesis in angulated necks.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry: An Analysis of Aortic Neck Coverage of the GORE® EXCLUDER® Conformable AAA Endoprosthesis With ACTIVE CONTROL System.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Inflammatory Aneurysm of the Common Iliac Artery With Elevated Serum Levels of Immunoglobulin G4 Manifesting After Endovascular Aneurysm Repair: A Case Report.
Cureus
View Source → PubMed • 2025
One-year outcomes from the pivotal trial of a four-branch off-the-shelf solution to treat pararenal and extent IV thoracoabdominal aortic aneurysms.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Wire wrap involving the celiac and superior mesenteric artery portals of the GORE EXCLUDER thoracoabdominal branch endoprosthesis: A multi-center case series.
Journal of vascular surgery cases and innovative techniques
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Total transfemoral approach for Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE), external tour de graft technique.
Journal of vascular surgery cases and innovative techniques
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2025
Component use of the GORE TAG thoracic branch endoprosthesis, GORE TAG conformable thoracic stent graft, GORE EXCLUDER thoracoabdominal branch endoprosthesis, and GORE EXCLUDER iliac branch endoprosthesis for the treatment of an extent II thoracoabdominal aortic aneurysm.
Journal of vascular surgery cases and innovative techniques
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2024
Three-year outcomes of a US pivotal trial substudy for conformable endoprosthesis in ≥10 mm nonangulated neck anatomy.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis.
BMJ surgery, interventions, & health technologies
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2023
Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.
Seminars in vascular surgery
View Source → PubMed • 2023
Technical pitfalls and proposed modifications of instructions for use for endovascular aortic aneurysm repair using the Gore Excluder conformable device in angulated and short landing zones.
Journal of vascular surgery cases and innovative techniques
Case Series View Source → PubMed • 2022
One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Protocol for GUo's renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study).
BMJ open
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Outcomes of Gore iliac branch endoprosthesis with internal iliac component versus Gore Viabahn VBX.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.
Journal of vascular surgery
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Gore Excluder AAA Endoprosthesis?
The device is indicated for the endovascular repair of infrarenal abdominal aortic aneurysms in patients who meet specific anatomical criteria.
What outcomes have been reported in clinical studies?
Clinical studies have reported favorable long-term outcomes, including reduced aneurysm-related mortality and sustained device patency.
What complications have been reported?
Safety data indicate complications such as inflammatory responses and serious adverse events, particularly in older patients.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.