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 November 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® 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 |
| 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 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 | 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 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 | Immediately after placement |
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
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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