GORE® TAG® Conformable Thoracic Stent Graft
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) Testing to a maximum MR system reported whole-body-averaged SAR of 3 W/kg for 15 minutes of scanning has also been found to be safe |
| Scan duration | 15 minutes of continuous scanning |
| Image artifact (3 tesla, gradient echo pulse sequence) | 10 mm relative to the size and shape of the vascular device |
| Time (post-implant) to safely scan | No restrictions in IFU |
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® Conformable Thoracic Stent Graft is indicated for endovascular repair of all lesions of the descending thoracic aorta, including isolated lesions, such as aneurysm and traumatic transection, and Type B dissections.
CONTRAINDICATIONS: The GORE® TAG® Conformable Thoracic Stent Graft is contraindicated in:
- Patients with known sensitivities or allergies to the device materials
- Patients with a systemic infection who may be at risk of endovascular graft infection