GORE® VIABAHN® FORTEGRA Venous Stent
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) | 1.5 T or 3.0 T |
| 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 5 mm 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 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 predilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
GORE® VIABAHN® FORTEGRA Venous Stent is not authorized for use in Canada.