GORE® VIABAHN® FORTEGRA Venous Stent
This device is labeled as MR Conditional. This means that the device has a demonstrated safety in a specified MRI environment with the defined conditions of use listed. The information on this page provides only a summary of MR conditions and is intended as a reference for EMEA only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of March 2026. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
A patient with the GORE® VIABAHN® FORTEGRA Venous Stent may be safely scanned immediately after placement under the following conditions. Failure to follow these conditions may result in injury.
| MR status | MR Conditional |
|---|---|
| Static Magnetic Field Strength (B0) | 1.5T or 3.0T |
| Maximum Spatial Field Gradient | 40 T/m (4,000 gauss/cm) |
| RF Excitation | There are no RF excitation restrictions |
| RF Transmit Coil Type | There are no Transmit Coil restrictions |
| Operating Mode | Normal Operating Mode |
| Maximum Whole-Body SAR | 2 W/kg (Normal Operating Mode) |
| Scan Duration | 2 W/kg whole-body averaged SAR for 60 minutes of continuous RF (a sequence or back to back series/scan without breaks) |
| MR Image Artifact | The presence of this implant may produce an image artifact. With a gradient echo pulse sequence in a 3.0T MR System, the artifact may extend up to 5mm from the implant. Under these conditions, the central portion of the lumen was visible. |
If information about a specific parameter is not included, there are no conditions associated with that parameter.
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.