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Magnetic Resonance Imaging (MRI) Safety Information for Devices Labeled as MR Conditional

The tables show the Gore devices that are labeled as MR conditional. This means that the devices have 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 for each device 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 July 2022. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.

GORE® VIABIL® Biliary Endoprosthesis/GORE® VIABIL® Short Wire Biliary Endoprosthesis

GORE® CARDIOFORM Septal Occluder

GORE® CARDIOFORM ASD Occluder

GORE® TAG® Conformable Thoracic Stent Graft

GORE® TAG® Thoracic Branch Endoprosthesis

GORE® EXCLUDER® AAA Endoprosthesis

GORE® EXCLUDER® Conformable AAA Endoprosthesis

GORE® EXCLUDER® Iliac Branch Endoprosthesis

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

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

GORE® VIATORR® TIPS Endoprosthesis/GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

 

GORE® VIABIL® Biliary Endoprosthesis/GORE® VIABIL® Short Wire Biliary Endoprosthesis

MR Status MR conditional
Static Magnetic Field Strengths 1.5 and 3.0 Tesla
Maximum Spatial Gradient 3000 Gauss/cm (30 T/m)
Max Whole-body-averaged Specific Absorption Rate (SAR) 4 W/kg (first level controlled mode)
Scan Duration 15 minutes of continuous scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) 5 mm from the device
The artifact does obscure the device lumen
Time (Post-Implant) to Safely Scan No restrictions listed in Instructions for Use

 

GORE® CARDIOFORM Septal Occluder

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 4000 Gauss/cm (40 T/m)
Max Whole-body-averaged Specific Absorption Rate (SAR) 4 W/kg (first level controlled operating mode)
Scan Duration 15 minutes of scanning (i.e., per pulse sequence)
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) In non-clinical testing, the image artifact caused by the GORE® CARDIOFORM Septal Occluder extends approximately 10 mm from this implant.
Time (Post-Implant) to Safely Scan No restrictions listed in Instructions for Use

GORE® CARDIOFORM ASD Occluder

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 4000 Gauss/cm (40 T/m) or less
Max Whole-body-averaged Specific Absorption Rate (SAR) <2 W/kg (normal operating mode)
Scan Duration 15 minutes of continuous scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) In non-clinical testing, the image artifact caused by the device extends approximately 5 mm from the GORE® CARDIOFORM ASD Occluder.
Time (Post-Implant) to Safely Scan Immediately after placement if conditions are met

GORE® TAG® Conformable Thoracic Stent Graft

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 3000 Gauss/cm (30 T/m)
Max Whole-body-averaged Specific Absorption Rate (SAR) 2.0 W/kg (normal operating mode)
Testing to a maximum MR system reported whole-body-averaged SAR of 3 W/kg for 15 minutes of scanning has also been found to be safe.
Scan Duration 15 minutes of continuous scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) 10 mm relative to the size and shape of the vascular device
Time (Post-Implant) to Safely Scan Immediately after placement

GORE® TAG® Thoracic Branch Endoprosthesis

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 3000 Gauss/cm (30 T/m)
Max Whole-body-averaged Specific Absorption Rate (SAR) 2.0 W/kg (normal operating mode)
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 artifact may extend up to 10 mm from the implant. Under these conditions, the central portion of the lumen of the aortic component was visible.
Time (Post-Implant) to Safely Scan Immediately after placement

GORE® EXCLUDER® AAA Endoprosthesis

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 3000 Gauss/cm or less
Max Whole-body-averaged Specific Absorption Rate (SAR) 2.0 W/kg (normal operating mode)
Scan Duration 15 minutes of scanning (i.e. per pulse sequence)
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) 10 mm
Time (Post-Implant) to Safely Scan Immediately after placement

GORE® EXCLUDER® Conformable AAA Endoprosthesis

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 3000 Gauss/cm (30 T/m) or less
Max Whole-body-averaged Specific Absorption Rate (SAR) 2 W/kg (normal operating mode)
Scan Duration 15 minutes of continuous scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) 8 mm from the device
The artifact does not obscure the device lumen
Time (Post-Implant) to Safely Scan Immediately after placement

GORE® EXCLUDER® Iliac Branch Endoprosthesis

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla only
Maximum Spatial Gradient 3000 Gauss/cm (30 T/m) or less
Max Whole-body-averaged Specific Absorption Rate (SAR) 4 W/kg (normal operating mode)
Scan Duration 15 minutes of continuous scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) 5 mm from the device
The artifact does not obscure the device lumen
Time (Post-Implant) to Safely Scan Immediately after placement

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 only
Maximum Spatial Gradient 3000 Gauss/cm or less
Max Whole-body-averaged Specific Absorption Rate (SAR)

4 W/kg (first level controlled mode)

For a GORE® VIABAHN® Endoprosthesis/GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 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 15 minutes of continuous scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) The image artifact extends up to 5 mm from the device. When the GORE® VIABAHN® Endoprosthesis/GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 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 No restrictions listed in Instructions for Use

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 Instructions for Use

GORE® VIATORR® TIPS Endoprosthesis/GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

MR Status MR conditional
Static Magnetic Field Strengths 1.5 Tesla or 3.0 Tesla
Maximum Spatial Gradient 720 Gauss/cm
Max Whole-body-averaged Specific Absorption Rate (SAR)

3.0 W/kg

Scan Duration 15 minutes of scanning
Image Artifact (3 Tesla, Gradient Echo Pulse Sequence) The image artifact extends approximately 2 mm from the device, both inside and outside the device lumen.
Time (Post-Implant) to Safely Scan No restrictions listed in Instructions for Use

Download the MR Conditional Model List

eIFU Symbol

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 each product is available. RX Only

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