Magnetic Resonance Imaging (MRI) Safety Information

This device is labeled as MR Conditional. This means a patient with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion may be safely scanned immediately after placement under the following conditions. If information about a specific parameter is not included, there are no conditions associated with that parameter. Failure to follow these conditions may result in injury.

The information on this page is current as of July 2024. For the most current MRI Safety Information on any product always refer to the IFU at eifu.goremedical.com
 

GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

Static magnetic field strengths (B0)1.5T or 3.0T
Maximum spatial field gradient40 T/m (4000 Gauss/cm)
RF excitationThere are not RF excitation restrictions
RF transmit coil typeThere are no transmit coil restrictions
Operating modeNormal operating mode
Maximum whole-body SAR2 W/kg (normal operating mode)
Scan duration2 W/kg whole body averaged SAR for 60 minutes of continuous RF (a sequence or back-to-back series/scan without breaks)
MRI image artifactThe presence of this implant may produce an image artifact. With a gradient echo pulse sequence, the artifact may extend up to 4 mm from the implant and may partially obscure the lumen.


For MRI safety information for the GORE® VIATORR® TIPS Endoprosthesis refer to the IFU at eifu.goremedical.com

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

24PL1039-EN01

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