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 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 May 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 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 | 2.0 W/kg whole-body averaged SAR for 60 minutes of continuous RF (a sequence or back to back series/scan without breaks) |
| MR image artifact | The presence of this implant may produce an image artifact. With a gradient echo pulse sequence in a 3.0T MR System, the artifact may extend up to 10mm 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 markets where this product is available. RX Only
INDICATIONS FOR USE: The GORE® TAG® Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel 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 target branch vessel 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 target branch vessel to the midpoint of any proximal branch vessel) of at least 2.0-4.0 cm, depending on Aortic Component selection; Proximal covered length (measured from distal edge of target branch vessel to the distal edge of any proximal branch vessel) of at least 15–36 mm, depending on Aortic Component selection; For patients with prior ascending aorta or aortic arch repair with surgical graft: at least 2 cm landing zone proximal to the distal anastomosis; Target Branch Vessel Landing Zone: Landing zone cannot be aneurysmal, dissected, heavily thrombosed and severely tortuous (180 degree turn within the treated length); Target branch vessel inner diameter of 6–18 mm, depending on Side Branch Portal diameter selected; Target branch vessel 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; Cannot be aneurysmal, dissected, heavily calcified or heavily thrombosed; 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.