📋 FDA Reference

gore r viabahn r fortegra venous stent

W.L. Gore & Associates

Summary: The GORE® VIABAHN® FORTEGRA Venous Stent is a medical device used to treat symptomatic inferior vena cava obstruction, with or without iliofemoral obstruction. It is primarily used by interventional radiologists and vascular surgeons.

FDA Clearance Information

Pathway PMA
Decision Date December 19, 2025
Product Code QTL
Device Class Class 3
Evidence 33 studies

The GORE® VIABAHN® FORTEGRA Venous Stent was cleared by the FDA through the premarket approval (PMA) pathway on December 19, 2025. Manufactured by W.L. Gore & Associates, it is classified as a Class III medical device.

What It Is

The GORE® VIABAHN® FORTEGRA Venous Stent is a flexible, self-expanding stent designed to maintain patency in the venous system, specifically for the inferior vena cava. It is constructed from a nitinol frame covered with an expanded polytetrafluoroethylene (ePTFE) lining, which provides a smooth luminal surface to enhance blood flow and minimize restenosis. This device is particularly useful in cases where venous obstruction can lead to significant morbidity if left untreated.

Clinical Applications

This stent is commonly used in interventional radiology and vascular surgery settings to treat patients with symptomatic venous obstructions. It is particularly relevant for patients with conditions such as deep vein thrombosis or post-thrombotic syndrome that result in inferior vena cava or iliofemoral obstruction. The device is typically deployed in a hospital setting, often in a catheterization lab or operating room, where imaging guidance can be used to ensure precise placement.

Indications for Use

The GORE® VIABAHN® FORTEGRA Venous Stent is intended for patients experiencing symptoms due to blockages in the inferior vena cava, which may or may not be accompanied by blockages in the iliofemoral veins. These blockages can cause significant symptoms such as leg swelling, pain, or skin changes.

Practical Considerations

The stent comes in various sizes to accommodate different patient anatomies and is compatible with standard delivery systems used in venous interventions. Clinicians should be familiar with the deployment technique, which involves fluoroscopic guidance to ensure accurate placement. Pre-procedural imaging is crucial to determine the appropriate stent size and length.

Linked Studies (20)

PubMed • 2025

Popliteal Arteriovenous Fistula Diagnosed Eight Years after Total Knee Arthroplasty. Endovascular Treatment with Viabahn® Endoprosthesis and Five-Year Follow-Up.

Reports (MDPI)

Other View Source →
PubMed • 2024

Mid-Term Outcomes of the Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent Graft for Fenestrated and Branched Endovascular Aortic Repair.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Laser Atherectomy and Restenting of the Superficial Femoral Artery Using GORE VIABAHN Endoprosthesis Following Failure of Both Bare-Metal Stenting and Surgical Revascularization.

Case reports in vascular medicine

View Source →
PubMed • 2024

Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study.

Vascular medicine (London, England)

Prospective View Source →
PubMed • 2024

Three-Year Results of the GORE VIABAHN Endoprosthesis in the Superficial Femoral Artery for In-Stent Restenosis.

Journal of the Society for Cardiovascular Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Erratum: Three-Year Results of the GORE VIABAHN Endoprosthesis in the Superficial Femoral Artery for In-Stent Restenosis.

Journal of the Society for Cardiovascular Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Viabahn endoprosthesis for femoropopliteal aneurysm repair: safety, success rates, and long-term patency.

CVIR endovascular

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

JMIR research protocols

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 • 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 • 2022

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Outcomes of chimney and fenestrated endografting using Viabahn VBX and atrium iCAST stents.

The Journal of cardiovascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Performance of the Gore VBX Balloon Expandable Endoprosthesis as Bridging Stent-Graft in Branched Endovascular Aortic Repair for Thoracoabdominal Aneurysms.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Bail-out technique to detach a locked Viabahn endoprosthesis in branched thoracic endovascular aortic repair.

Journal of vascular surgery cases and innovative techniques

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair.

Annals of vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

Surgeon custom-made iliac branch device to salvage hypogastric artery during endovascular aneurysm repair.

Journal of Korean medical science

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2014

Transaortic modification of the Viabahn open revascularization technique (VORTEC) to facilitate renal artery revascularization in a hybrid EVAR procedure.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012

ViPS (Viabahn Padova Sutureless) technique: preliminary results in the treatment of peripheral arterial disease.

Annals of vascular surgery

Other View Source →
PubMed • 2012

New surgical and hybrid techniques for crural and pedal anastomoses.

The Journal of cardiovascular surgery

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What is the GORE® VIABAHN® FORTEGRA Venous Stent used for?

It is used to treat symptomatic blockages in the inferior vena cava, with or without iliofemoral obstruction.

What specialties typically use this device?

Interventional radiologists and vascular surgeons commonly use this device.

What are the FDA-cleared indications?

It is indicated for treating symptomatic inferior vena cava obstruction, with or without iliofemoral obstruction.

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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