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® 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 IFU

eIFU Symbol

INDICATIONS FOR USE: The GORE® VIATORR® TIPS Endoprosthesis is indicated for use in the de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, refractory ascites and/or hepatic hydrothorax. CONTRAINDICATIONS: There are no known contraindications for this device. 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. RX Only

231105103-EN

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