GORE® TAG® Thoracic Branch Endoprosthesis
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 EMEA only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of March 2025. 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 or 3.0 Tesla |
| Maximum spatial gradient | 3000 gauss/cm (30 T/m) |
| Max whole-body-averaged specific absorption rate (SAR) | 2.0 W/kg (normal operating mode) |
| 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 artifact may extend up to 10 mm from the implant. Under these conditions, the central portion of the lumen of the aortic component was visible. |
| Time (post-implant) to safely scan | Immediately after placement |
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the market where this product is available. RXOnly
INDICATIONS FOR USE IN EUROPE: The GORE® TAG® Thoracic Branch Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta (including isolated lesions, such as aneurysm and traumatic transection, and Type B dissections) while maintaining flow into the left subclavian artery, in patients who have appropriate anatomy.
CONTRAINDICATIONS: The GORE® TAG® Thoracic Branch Endoprosthesis is contraindicated in: Patients with known sensitivities or allergies to the device materials [ePTFE (polytetrafluoroethylene), FEP (Fluoroethylpropylene), Nitinol (Nickel, Titanium), Gold, SB Component only - Heparin (CBAS® Heparin surface]; Patients who have a condition that threatens to infect the graft; Patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.