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 the U.S. only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of November 2022. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
|MR status||MR Conditional|
|Static magnetic field strengths||1.5 tesla or 3.0 tesla only|
|Maximum spatial gradient||1000 gauss/cm or less|
|Max whole-body-averaged specific absorption Rate (SAR)||
2 W/kg (normal operating mode)
|Scan duration||15 minutes of scanning (i.e. per pulse sequence)|
|Image artifact (3 Tesla, gradient echo pulse sequence)||15 mm from the device|
|Time (post-implant) to safely scan||No restrictions listed in IFU|
INTENDED USE/INDICATIONS: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm–13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation. CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 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. RX Only