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® 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)
Maximum 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 IFU

 

*Note: GORE® VIABIL® Short Wire Biliary Endoprosthesis is not licensed in Canada in accordance with the Canadian Medical Device Regulation SOR/98-282.

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 this product is available. RXOnly


FOR ENDOSCOPIC DELIVERY IN THE U.S.
INDICATIONS: (Non-Removable) The GORE® VIABIL® Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree.
CONTRAINDICATIONS: The GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. 

FOR GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS FOR ENDOSCOPIC DELIVERY IN THE U.S.
INDICATIONS: (Non-Removable) The GORE® VIABIL® Short Wire Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree.
CONTRAINDICATIONS: The GORE® VIABIL® Short Wire Biliary Endoprosthesis is contraindicated for. All CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. 

FOR PERCUTANEOUS DELIVERY IN THE U.S.
INDICATIONS: (Non-Removable) The GORE® VIABIL® Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree.
CONTRAINDICATIONS: The GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. 

FOR ENDOSCOPIC DELIVERY IN CANADA
INDICATIONS: (Non-Removable): The GORE® VIABIL® Biliary Endoprosthesis is indicated for palliation of malignant strictures in the biliary tree. (Removable): The Removable GORE® VIABIL® Biliary Endoprosthesis is indicated for the treatment of benign and malignant biliary strictures and can be removed from such strictures for up to one year post implant.
CONTRAINDICATIONS: (Non-Removable): The GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter. (Removable): The Removable GORE® VIABIL® Biliary Endoprosthesis is contraindicated for: ALL CARDIOVASCULAR APPLICATIONS; ducts less than 5.5 mm in diameter or greater than 9 mm in diameter and removal when positioned within a previously placed bare metal stent. 

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