gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface
W.L. Gore & Associates
FDA Clearance Information
The Gore Viabahn Endoprosthesis was cleared via the PMA pathway on April 10, 2014. Manufactured by W.L. Gore & Associates, it is classified as a Class III 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 Gore Viabahn Endoprosthesis?
The device is indicated for the treatment of peripheral artery disease, particularly in complex femoropopliteal lesions and in-stent restenosis.
What outcomes have been reported in clinical studies?
Studies report primary patency rates of 62.4% and secondary patency rates of 82.3%, 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 stent fractures observed.