Made to conform, not compress
Experience the FORTEGRA Venous stent indicated for use in the treatment of symptomatic inferior vena cava and iliofemoral venous outflow obstruction. Purpose-built for iliocaval obstruction, the FORTEGRA Venous Stent combines proven Gore technology and a unique design to deliver an optimal balance of conformability and compression resistance — with the high flexibility you need to treat with confidence in high-movement areas of anatomy.
Made for patients with deep venous disease
Engineered with proprietary Gore materials, with an open-structure, self-expanding nitinol wire frame and expanded polytetrafluoroethylene (ePTFE) polymer lattice, designed for conformability, strength and flexibility.
Proven clinical outcomes for safety and effectiveness1
In the first venous stent study of its kind to include patients with extensive disease burden—notably all thrombotic patients (acute, subacute and post-thrombotic syndrome)—the FORTEGRA Venous Stent met the primary endpoint composite score for efficacy and safety at 12 months.
Patency results at 12 months
primary patency
secondary patency
Safety results
embolizations
migrations
fractures
vascular injury or clinically significant pulmonary embolism
device-related deaths or major bleeding through 30 daysa
Made to help more patients
The FORTEGRA Venous Stent offers a broad size range, empowering physicians to treat more vessels and a wider spectrum of deep venous disease.
| Labeled device diameter (mm) | Recommended vessel diameter (mm) | Introducer sheath size (Fr)b | Available device lengths (mm) | Guidewire diameter (Stiff) |
|---|---|---|---|---|
| 10 | 7–9 | 10 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 12 | 9–11 | 11 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 14 | 11–13 | 11 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 16 | 13–15 | 11 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 18 | 15–17 | 12 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 20 | 17–19 | 12 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 24 | 18–22 | 14 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
| 28 | 22–26 | 14 | 50, 75, 100, 150 | 0.035" (0.889 mm) |
Related to this product
a. One death and four major bleed events were adjudicated as procedure related by the site and clinical events committee (CEC).
b. All devices are compatible with the GORE® DRYSEAL Sheath at the profiles noted in Table 1. If necessary, sheaths may be upsized by ≥1 Fr.
- GORE® VIABAHN® FORTEGRA Venous Stent 10-20 mm devices are not compatible with the Cook CHECK-FLO® FLEXOR® sheath or the Abbott FAST-CATH™ Introducer sheath at the profiles noted above.
- The 16 mm diameter device is not compatible with the Cordis AVANTI® Sheath Introducer or the Cordis BRITE TIP® Sheath Introducer at the profile noted above.
- Do not use any introducer sheath that does not have an atraumatic tip (e.g., Inari Protrieve™ Sheath).
- Data on File, 2025, MD206399, W. L. Gore & Associates, Inc., Flagstaff, AZ. Clinical Evaluation Report for GORE® VIABAHN® FORTEGRA Venous Stent.
Gore received Breakthrough Device designation from the FDA for the FORTEGRA Venous Stent. This program helps expedite the development and FDA review of medical devices that offer more effective treatment for life-threatening or irreversibly debilitating disease and conditions.
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
INDICATIONS FOR USE IN EMEA: The GORE® VIABAHN® FORTEGRA Venous Stent is indicated for use in the treatment of symptomatic inferior vena cava and iliofemoral venous outflow 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.