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Gore R Viabahn R Vbx Balloon Expandable Endoprosthesis
Product: GORE VIABAHN VBX Balloon Expandable Endo — all models and sizes
Summary: The Gore VIABAHN VBX is a balloon-expandable endoprosthesis used primarily in vascular interventions. It is designed for use by interventional radiologists and vascular surgeons to treat occlusive disease in peripheral arteries.
FDA Clearance Information
Pathway ?
PMA
Number ?
P160021 ↗
Decision Date ?
October 17, 2025
Product Code ?
PRL Iliac Covered Stent, Arterial
Device Class ?
Class 3
Evidence ?
33 studies
The Gore VIABAHN VBX received FDA clearance under PMA P160021 on October 17, 2025. Manufactured by W.L. Gore & Associates, it is classified as a Class 3 medical device.
What It Is
The Gore VIABAHN VBX is a balloon-expandable endoprosthesis designed to treat vascular occlusions. It features a heparin-coated surface to reduce thrombogenicity and is used to restore blood flow in peripheral arteries. The device is typically inserted via a catheter and expanded using a balloon to fit the vessel's diameter.
FDA-Cleared Indications
- Treatment of stenotic or occlusive disease in the iliac arteries.
- Revascularization of peripheral arterial lesions when an endovascular covered-stent treatment is indicated.
- Use in adult patients with peripheral arterial disease requiring iliac artery revascularization.
Clinical Applications
- Endovascular treatment of iliac artery stenosis or occlusion.
- Placement during peripheral artery stenting to create a supported channel for blood flow.
- Treatment of iliac artery disease as an alternative to open surgical bypass when appropriate.
- Use by interventional radiologists or vascular surgeons during catheter-based peripheral revascularization.
Reported off-label uses
- Treatment of selected peripheral arterial aneurysms or pseudoaneurysms outside the labeled iliac occlusive-disease indication.
- Use in selected visceral or other peripheral arterial lesions when clinicians determine that a covered balloon-expandable stent is appropriate.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The device is available in multiple diameters and lengths; accurate vessel and lesion measurement is required for sizing.
- It is delivered through a compatible catheter system and expanded with a balloon under fluoroscopic or other suitable imaging guidance.
- Patients with contrast allergy, kidney disease, bleeding disorders, severe calcification, or infection require individualized assessment before treatment.
- MRI conditions and allowable scan parameters must be confirmed in the current manufacturer instructions for use; the device should not be assumed to be unrestricted MRI safe.
- Antiplatelet or anticoagulant treatment, access-site management, and follow-up imaging may be required according to the treating clinician's plan.
Related Literature
The linked study investigated the use of the Gore VIABAHN VBX in treating occlusive disease in the iliac arteries. While specific results are not available, the study likely assessed the device's efficacy and safety in restoring blood flow. Limitations may include a lack of long-term outcome data and a small sample size.
Procedures that use this device
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 VBX used for?
It is used to treat occlusive disease in peripheral arteries, particularly the iliac arteries.
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 the treatment of occlusive disease in the iliac arteries.
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.