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gore excluder thoracoabdominal branch endoprosthesis
W.L. Gore & Associates
Summary: The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is an endovascular device used for the repair of thoracoabdominal aortic aneurysms. Key evidence highlights its use in complex aneurysm cases with a focus on safety and efficacy.
FDA Clearance Information
Pathway
PMA
Number
P230023 ↗
Decision Date
August 13, 2024
Product Code
QZK
Device Class
Class 3
Evidence
40 studies
The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis received FDA premarket approval (PMA) on August 13, 2024. Manufactured by W.L. Gore & Associates, it is classified as a Class III device.
What It Is
The GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis is a stent graft system designed for endovascular repair of thoracoabdominal aortic aneurysms. It features preloaded guidewires to facilitate branch vessel cannulation.
Clinical Applications
This device is commonly used in the treatment of complex thoracoabdominal aortic aneurysms, particularly in patients who are not candidates for open surgical repair. It provides a minimally invasive option for aneurysm management.
Evidence Summary
The available literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies, published around 2025, provide insights into the device's performance and safety.
Reported Outcomes
Published studies report that the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis demonstrates promising outcomes in the repair of thoracoabdominal aortic aneurysms. One-year outcomes from pivotal trials indicate effective aneurysm exclusion and branch vessel patency.
Safety Profile
Reported complications include technical difficulties such as wire wrapping during catheterization, which can affect bridge stent delivery. However, overall safety profiles are consistent with other endovascular devices used in similar clinical settings.
Evidence Limitations
Current evidence is limited by the relatively short follow-up duration and the complexity of cases treated. Further research is needed to assess long-term outcomes and to optimize procedural techniques.
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 Thoracoabdominal Branch Endoprosthesis?
The device is indicated for the endovascular repair of thoracoabdominal aortic aneurysms, particularly in patients unsuitable for open surgical repair.
What outcomes have been reported in clinical studies?
Clinical studies report effective aneurysm exclusion and branch vessel patency at one-year follow-up, with promising short-term outcomes.
What complications have been reported?
Safety data indicate complications such as wire wrapping during catheterization, which can impact stent delivery, but overall safety is comparable to similar devices.
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.