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® TAG® Conformable Thoracic Stent Graft
|MR status||MR Conditional|
|Static magnetic field strengths||1.5 tesla or 3.0 tesla only|
|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||Immediately after placement|
INDICATIONS FOR USE IN THE U.S.: The GORE® TAG® Conformable Thoracic Stent Graft is intended for endovascular repair of all lesions of the descending thoracic aorta, including: Isolated lesions in patients who have appropriate anatomy, including: adequate iliac/femoral access, aortic inner diameter in the range of 16–42 mm, ≥ 20 mm non-aneurysmal aorta proximal and distal to the lesion; Type B dissections in patients who have appropriate anatomy, including: adequate iliac/femoral access, ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected, diameter at proximal extent of proximal landing zone in the range of 16–42 mm. CONTRAINDICATIONS: Patients with known sensitivities or allergies to the device materials; patients who have a condition that threatens to infect the graft. 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