📊 Evidence-Based Reference

gore excluder conformable aaa endoprosthesis excc

W. L. Gore And Associates

Summary: The Gore Excluder Conformable AAA Endoprosthesis is a stent-graft designed for endovascular aneurysm repair (EVAR) in patients with challenging aortic neck anatomies. Key evidence highlights its adaptability and efficacy in reducing complications like endoleaks.

FDA Clearance Information

Pathway PMA
Decision Date November 2, 2023
Product Code MIH
Device Class Class 3
Evidence 40 studies

The Gore Excluder Conformable AAA Endoprosthesis received FDA premarket approval (PMA) on November 2, 2023. Manufactured by W. L. Gore And Associates, it is classified as a Class III medical device.

What It Is

The Gore Excluder Conformable AAA Endoprosthesis is a flexible stent-graft system used in endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAA). It is designed to conform to challenging aortic neck anatomies, improving graft fixation and reducing the risk of complications.

Clinical Applications

This device is commonly used in patients with abdominal aortic aneurysms, particularly those with hostile neck anatomies characterized by severe angulation, short neck length, or conical shapes. It provides a minimally invasive option for patients who may not be candidates for open surgical repair.

Evidence Summary

The available literature includes 13 studies, comprising various study types such as RCTs, prospective, and retrospective analyses, conducted between 2024 and 2025. These studies focus on the device's performance in challenging anatomical scenarios.

Reported Outcomes

Published studies report that the Gore Excluder Conformable AAA Endoprosthesis demonstrates effective aneurysm exclusion and reduced incidence of type I and III endoleaks. The device's adaptability to hostile neck anatomies has been associated with improved aortic remodeling and distal sealing.

Safety Profile

Reported complications include stent graft migration and type I endoleaks, particularly in cases with extreme anatomical challenges. However, the device's design aims to mitigate these risks by enhancing conformability and fixation.

Evidence Limitations

Current evidence is limited by short to mid-term follow-up periods and a focus on specific anatomical challenges. Further research is needed to evaluate long-term outcomes and broader applicability across diverse patient populations.

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 Conformable AAA Endoprosthesis?

The device is indicated for endovascular repair of abdominal aortic aneurysms, especially in patients with hostile neck anatomies.

What outcomes have been reported in clinical studies?

Studies have reported effective aneurysm exclusion, reduced type I and III endoleaks, and improved aortic remodeling.

What complications have been reported?

Safety data indicate potential complications such as stent graft migration and type I endoleaks, particularly in challenging anatomies.

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.

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