gore excluder conformable aaa endoprosthesis excc
W. L. Gore And Associates
FDA Clearance Information
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
Clinical Applications
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Linked Studies (20)
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 →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 →Conformable Endovascular Aneurysm Repair (EVAR) Stability in Hostile Neck Abdominal Aortic Aneurysms: A Single-Center Experience.
Cureus
View Source →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 →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 →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 →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 →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 →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 →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 →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 →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 →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 →Emergent endovascular treatment options for thoracoabdominal aortic aneurysm.
Seminars in vascular surgery
View Source →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 →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 →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 →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 →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 →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.