GORE® VIABAHN® Endoprosthesis / GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface*
This device is labeled as MR Conditional. This means that the devices 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 November 2022. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
| 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, PROPATEN Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
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
INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:
- de novo or restenotic lesions in the iliac arteries
- de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
- in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
- stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
- popliteal artery aneurysms and isolated visceral artery aneurysms
- 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:
- 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 PROPATEN 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.