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® Thoracic Branch Endoprosthesis
|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)|
|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|
INDICATIONS FOR USE IN THE U.S.: The GORE® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery, in patients who have: Adequate iliac/femoral access; Proximal Aortic Landing Zones: For Isolated Lesion Patients: Proximal landing zone cannot be aneurysmal, dissected, heavily calcified, or heavily thrombosed; For Dissection Patients: Primary entry tear must be distal to the left subclavian artery and the proximal extent of the landing zone must not be dissected; Aortic inner diameter range 16–42 mm; Proximal segment length (length from distal edge of left subclavian artery to mid left common carotid ostium) of at least 2.0–4.0 cm, depending on Aortic Component selection; Proximal covered length (measured from distal edge of left subclavian artery to distal edge of left common carotid artery ostium) of at least 15–36 mm, depending on Aortic Component selection; For patients with prior ascending aorta or aortic arch repair with a surgical graft: at least 2 cm landing zone proximal to the distal anastomosis; Left Subclavian Landing Zone: Not aneurysmal, dissected, heavily calcified, or heavily thrombosed and without severe tortuosity (180 degree turn within the treated length); Left subclavian artery inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected; Left subclavian artery minimum length of 2.5–3.0 cm, depending on Side Branch Portal diameter selected. Distal Landing Zone (Isolated Lesion Patients only): Outer curve length must be ≥ 2 cm proximal to celiac artery; Aortic inner diameter range 16–42 mm; Non aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone; Native Aorta or previously placed GORE®TAG® Conformable Thoracic Stent Graft. 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. 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