Magnetic Resonance Imaging (MRI) Safety Information

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® Endoprosthesis/GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface*

MR status MR Conditional
Static magnetic field strengths 1.5 tesla or 3.0 tesla
Maximum spatial gradient 30 T/m (3000 gauss/cm)
Max whole-body-averaged specific absorption rate (SAR)

2 W/kg (normal operating mode)

For a VIABAHN® Device placed within a bare nitinol stent, the lesser of the maximum whole-body averaged SAR reported in the bare nitinol stent’s Instructions for Use, or the maximum whole-body averaged SAR of 2.0 W/kg should be used.
Scan duration 60 minutes of continuous RF (a sequence or back to back series/scan without breaks) 
Image artifact (3 tesla, gradient echo pulse sequence)

The presence of this implant may produce an image artifact. With a gradient echo pulse sequence, the artifact may extend up to 5 mm from the implant and may obscure the lumen. When the VIABAHN® Device was placed within a bare nitinol stent the image artifact extended up to 20 mm from the devices. Artifacts extended both inside and outside the device lumen.
Time (post-implant) to safely scan Immediately after placement

* As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.

eIFU Symbol

INTENDED USE / INDICATIONS: The GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface are indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0–7.5 mm. The GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface are indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0–6.5 mm. The GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface are indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0–12 mm. The GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface are indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface are contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. RX Only

231084057-EN

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