Chronic venous disease is a widespread vascular condition, often affecting a younger patient population, imposing broader economic, and societal costs beyond direct medical expenses.1,2

 

Breakthrough Device Designation

This stent received Breakthrough Device Designation, a recognition given to certain medical devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions when no approved alternative exists. The FORTEGRA Venous Stent represents a major advancement in care for patients with obstructive venous disease, helping restore healthy blood flow to improve quality of life.4

 

Integrated device portfolio

The FORTEGRA Venous Stent is designed to support seamless stenting of both the IVC and iliofemoral veins using devices that are engineered and tested together.3 This compatibility supports procedural efficiency and consistent performance across the venous system.

The GORE® VIABAHN® FORTEGRA Venous Stent offers the widest range of diameter configurations and comparable length offerings among self-expanding venous stents.3, 5-9
Chart showing product diameters and lengths for a variety of stents
Differentiation from competitors

Unlike competitor portfolios, which lack large diameter devices (> 20 mm),3, 5-9 our devices provide an on-label solution for treating iliocaval obstructive disease in the confluence configuration.

The confluence configuration not only simplifies the procedure but may also reduce the total number of stents required when compared to the double-barrel configuration.

Confluence configuration advantage

The confluence configuration closely replicates physiological flow seen in healthy veins.10 It promotes:

  • Improved blood mixing
  • Sustained forward flow
  • Reduced areas of stagnation, which are associated with thrombus formation
IVC + bilateral iliofemoral confluence
IVC + bilateral iliofemoral confluence
IVC + bilateral iliofemoral double-barrel
IVC + bilateral iliofemoral double-barrel

Meaningful improvements in clinical and quality of life scores

The VIAHBAHN® FORTEGRA Venous Stent represents a major advancement in care for patients with obstructive venous disease, helping restore healthy blood flow to improve quality of life.4

Revised venous clinical severity score (rVCSS) 

A physician-administered tool used to assess the severity of chronic venous insufficiency.a,3

  • Statistically significant improvements were observed in 4 of 8 rVCSS parameters for patients with baseline scores > 0 (P < 0.001), including:
    • Skin quality
    • Ulcer healing
    • Pain reduction
    • Decreased venous swelling
  • Patients with a pain baseline score of 0 experienced no worsening of symptoms.
  • Additional parameters — varicose veins, inflammation, pigmentation and reduced use of compression therapy — showed favorable trends, though not statistically significant.
EQ-5D-5L Quality of Life Assessment

A standardized, patient-reported tool measuring health-related quality of life across 5 dimensions.3

  • At 12 months, patients reported improvements in:
    • Mobility
    • Self-care
    • Usual activities
    • Pain/discomfort
  • No change was observed in the anxiety/depression dimension, indicating stability in mental health outcomes. 

Inventory efficiency

The GORE® VIABAHN® FORTEGRA Venous Stent portfolio offers a comprehensive range of device sizes — delivered in compact packaging designed to optimize limited shelf space. Compared to competitor offerings,a this streamlined inventory approach supports procedural flexibility while reducing storage demands.

 

Depth
(cm)

Width
(cm)

Length
(cm)

Volume
(cc)

Volume relative
to VIABAHN®
FORTEGRA
Device

GORE® VIABAHN® FORTEGRA Venous Stent

1.7

28.5

30

1,454

 

MEDTRONIC® ABRE™ Venous Self-Expanding
Stent System

3.4

14.5

139.5

6,877

473%

BD® VENOVO® Venous Stent System

4.5

24

52

5,616

386%

COOK® ZILVER VENA® Venous
Self-Expanding Stent

2.5

30

58

4,350

299%

BOSTON SCIENTIFIC® VENOUS WALLSTENT
Self-Expanding Stent

2

12

129.5

3,108

214%

Product packaging showing the various box sized of the products

Cost-efficient planning

Image of Calculator Icon Red

The VIABAHN® FORTEGRA Device cost calculator is a powerful planning tool that accounts for stent sizes — both lengths and diameters — as well as stenting configurations. It clearly demonstrates the impact of stenting configuration on device utilization and costs between current iliocaval stenting practices and future approaches using the VIABAHN® FORTEGRA Device.

By optimizing stent selection and configuration, clinicians can reduce overall device usage and enhance procedural efficiency — potentially lowering total treatment costs. 
 

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Related Pages 

a. Data on file 2025; W. L. Gore & Associates, Inc; Flagstaff, AZ.
b. Centers for Medicare & Medicaid Services. Using the ICD-10-PCS new technology section codes. Accessed March 2, 2026. https://www.cms.gov/files/document/using-icd-10-pcs-new-technology-section-codes.pdf

  1. Shamimi-Noori SM, Clark TWI. Venous stents: current status and future directions. Techniques in Vascular & Interventional Radiology 2018;21(2):113-116.
  2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons N. Burden of venous leg ulcers in the United States. Journal of Medical Economics 2014;17(5):347-356.
  3. GORE® VIABAHN® FORTEGRA Venous Stent [Instructions for Use] W. L. Gore & Associates, Inc; 2025. MD205743. Rev. 2.
  4. Breakthrough Devices Program. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#s1
  5. Abre Venous Self-Expanding Stent System. Medtronic. Accessed October 15, 2025. https://www.medtronic.com/en-us/healthcare-professionals/products/cardiovascular/deep-venous-stents/abre-venous-self-expanding-stent-system.html
  6. Duo Venous Stent System Brochure. Phillips. Accessed October 15, 2025. https://www.documents.philips.com/assets/20240228/7c944a39124a4077a4afb124014e4772.pdf
  7. ZilverR Vena™ Venous Self-Expanding Stent [Instructions for Use] Cook Ireland LTD; 2021. IFU0091-8. https://ifu.cookmedical.com/data/IFU_PDF/IFU0091-8.PDF
  8. Venovo™ Venous Stent System. Becton, Dickinson and Company. Accessed October 15, 2025. https://www.bd.com/en-us/products-and-solutions/products/product-families/venovo-venous-stent-system
  9. Venous Wallstent Self-Expanding Stent Brochure. Boston Scientific Corporation. PI-781701-AA. Accessed October 15, 2025. https://www.bostonscientific.com/content/dam/bostonscientific/pi/portfolio-group/Stents/WALLSTENT-Endo/Resources/Wallstent_Venous_Brochure_(PI-781701-AA).pdf
  10. Abramowitz S. Computational fluid dynamics analysis: comparative assessment of venous stent configurations in the IVC. Presented at the 39th Annual Eastern Vascular Society Meeting; September 4-7, 2025; Nashville, TN.
IFU Consult instructions

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

Products listed may not be approved in all markets.

INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® FORTEGRA Venous Stent is indicated for use in the treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction.

CONTRAINDICATIONS: The GORE® VIABAHN® FORTEGRA Venous Stent is contraindicated for use in patients with lesions where expansion of an angioplasty balloon catheter to minimum GORE® VIABAHN® FORTEGRA Venous Stent recommended vessel diameters was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.

26PR1008-EN01 MAT-0264-1