Devices
Join the next generation of care in the treatment of aortoiliac occlusive disease
The latest generation of covered stent grafts
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft)
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface* (GORE® VIABAHN® Device)
VBX Stent Graft
Decide with data
5-year follow-up shows the VBX Stent Graft continues to be a long-term durable treatment option for complex aortoiliac occlusive disease (AIOD).1
The Gore VBX FLEX Clinical Study 3-year follow-up found the VBX Stent Graft to be a robust and durable treatment option for AIOD.2 Now, sustained patient benefit and durability are demonstrated through 5 years.
Physician-initiated 5-year VBX Stent Graft follow-up
Objective and methodology1
- This physician-initiated study enrolled 59 of the initial 134 patients from 3 participating centers that were representative of the VBX FLEX Study 3-year follow-up cohort. 28 patients completed the 5-year follow-up.
- The primary durability endpoint was long-term primary patency.
DURABLE CLINICAL OUTCOMES THROUGH 5 YEARS1:
89.5%
primary patency per lesion
96.1%
primary assisted patency per lesion
89.1%
freedom from target lesion revascularization per subject
SUSTAINED PATIENT BENEFIT THROUGH 5 YEARS1:
100%
of evaluated (n=28) patients improved ≥ 1 Rutherford category from baseline†,1
.15
improvement in mean resting ankle-brachial index (ABI)
(P < .001, .95 mean ABI)‡
3x
improvement in median WIQ measures
The case for long-term durable clinical outcomes:
GORE® VIABAHN® Device
Durable clinical outcomes and proven patency even in complex cases.$
GORE® VIABAHN® DEVICE OUTCOMES IN ILIAC OCCLUSIVE DISEASE
Retrospective multicenter study, evaluating the performance of the GORE® VIABAHN® Device (n = 93) for the treatment of external iliac artery obstructive disease.
89.8%
Primary patency at 42 months3
91%
Secondary patency at 42 months3
94.6%
Limb salvage rate at 42 months3
*As used by Gore, PROPATEN Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
† 59 subjects participated and 28 were available through the end of the study at 5-year follow-up.
‡ (P < .001) Statistically significant change from pre-procedure.
§ Complex defined as TASC II classification C & D lesions.
- Holden A, Takele E, Hill A, et al. Long-Term Follow-up of Subjects With Iliac Occlusive Disease Treated With the Viabahn VBX Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy. 2023;0(0). doi:10.1177/15266028231165723.
- Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736.
- Squizzato, F., Mosquera-Rey, V., Zanabili Al-Sibbai, A. et al. Outcomes of Self-Expanding Covered Stents for the Treatment of External ILIAC Artery Obstructive Disease. Cardiovasc Intervent Radiol 46, 579–587 (2023). https://doi.org/10.1007/s00270-023-03370-9
CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:
- de novo or restenotic lesions in the iliac arteries
- de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
- in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
- stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
- popliteal artery aneurysms and isolated visceral artery aneurysms
- traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries)
CONTRAINDICATIONS:
- Non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
- Do not use the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:
- de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation;
- de novo or restenotic lesions in the visceral arteries;
- isolated visceral, iliac, and subclavian artery aneurysms; or
- traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for use as a bridging stent in branched and fenestrated endovascular aortic aneurysm repair with the following:
- Approved for use branched aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and polypropylene suture with branch diameters of 6/8 mm and lengths of 18/21 mm.
- Approved for use fenestrated aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and fenestrations with polypropylene suture ranging in diameter from 6–8 mm.
CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.