viabahn endoprosthesis
W.L. Gore & Associates
FDA Clearance Information
The Viabahn Endoprosthesis was cleared by the FDA via the 510(k) pathway on January 8, 2002. It is manufactured by W.L. Gore & Associates and is classified as a Class 2 device.
What It Is
Clinical Applications
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Linked Studies (20)
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 →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 →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 →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 →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 →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 →Viabahn endoprosthesis for femoropopliteal aneurysm repair: safety, success rates, and long-term patency.
CVIR endovascular
RCT|prospective|retrospective|case Series|other View Source →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 →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 →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 →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 →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 →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 →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 →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 →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 →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 →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 →ViPS (Viabahn Padova Sutureless) technique: preliminary results in the treatment of peripheral arterial disease.
Annals of vascular surgery
Other View Source →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 are the clinical indications for Viabahn Endoprosthesis?
The Viabahn Endoprosthesis is indicated for the treatment of peripheral artery disease, particularly in cases of in-stent restenosis and complex femoropopliteal lesions.
What outcomes have been reported in clinical studies?
Clinical studies have reported primary patency rates of 62.4% and secondary patency rates of 82.3% over five years, with significant improvements in Rutherford class.
What complications have been reported?
Reported complications include a 19.9% rate of device-related serious adverse events, with no observed stent fractures.