Slideshow of doctors

GORE® VIABAHN® Device family

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

Five-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 three-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 five years.

Physician-initiated five-year VBX Stent Graft follow-up
 

Objective and methodology1
 

  • This physician-initiated study enrolled 59 of the initial 134 patients from three participating centers that were representative of the VBX FLEX Study three-year follow-up cohort. 28 patients completed the five-year follow-up.
  • The primary durability endpoint was long-term primary patency.

 

DURABLE CLINICAL OUTCOMES THROUGH FIVE 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 FIVE YEARS1:

89%

of patients improved ≥ 1 Rutherford category from baseline

.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:

Case study 1: Restoring flow to a patient with stenosis at the aortoiliac bifurcation
Case study 2: Restoring flow in a patient with severe claudication and focal iliac calcification

GORE® VIABAHN® Device

Durable clinical outcomes and proven patency in complex cases.

VIABAHN® Device

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.

†(P < .001) Statistically significant change from pre-procedure.

  1. 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.
  2. 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.
  3. 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

eIFU Symbol

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

CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc

23959700-EN

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