GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
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 EMEA only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of March 2025. 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 |
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 | 60 minutes of continuous RF |
| Image artifact (3 Tesla, gradient echo pulse sequence) | 15 mm from the device |
| Time (post-implant) to safely scan | No restrictions listed in IFU |
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
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:
- de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;
- de novo or restenotic lesions in the visceral arteries;
- isolated visceral, iliac, and subclavian artery aneurysms; or
- traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for use as a bridging stent in branched and fenestrated endovascular aortic aneurysm repair with the following:
- Approved for use branched aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and polypropylene suture with branch diameters of 6/8 mm and lengths of 18/21 mm.
- Approved for use fenestrated aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and fenestrations with polypropylene suture ranging in diameter from 6–8 mm.
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.
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile)
INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:
- de novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;
- de novo or restenotic lesions in the visceral arteries;
- isolated visceral, iliac, and subclavian artery aneurysms; or
- traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).
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.