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 February 2024. For the most current and complete MR safety information on any product, always refer to the IFU.

GORE® Hybrid Vascular Graft (Product has been discontinued)

MR statusMR Conditional
Static magnetic field strengths1.5 tesla or 3.0 tesla
Maximum spatial gradient720 gauss/cm
Max whole-body-averaged specific absorption rate (SAR)3.0 W/kg
Scan duration15 minutes of scanning
Image artifact (3 tesla, gradient echo pulse sequence)The image artifact extends approximately 4 mm from the device, both inside and outside the device lumen.
Time (post-implant) to safely scanNo restrictions listed in IFU

Consult Instructions for Use symbol

INDICATIONS FOR USE: GORE® Hybrid Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures. 
CONTRAINDICATIONS: 1. DO NOT use the GORE® Hybrid Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of HIT type II. 2. DO NOT use any configuration of GORE® Hybrid Vascular Grafts for coronary artery bypass or cerebral reconstruction procedures. 3. DO NOT use GORE® Hybrid Vascular Grafts as a patch. If cut and used as a patch, GORE® Hybrid Vascular Grafts may lack adequate transverse strength. FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE® ACUSEAL Cardiovascular Patch.
Refer to Instructions for Use for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

Product has been discontinued and is not available in any market.


 

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