GORE® TIGRIS® Vascular Stent (Product has been discontinued)
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 February 2024. For the most current and complete MR safety information on any product, always refer to the IFU.
| MR status | MR Conditional |
|---|---|
| Static magnetic fields strength | 1.5 tesla or 3.0 tesla |
| Maximum spatial gradient | 4000 gauss/cm |
| Max whole-body-averaged specific absorption rate (SAR) | 4.0 W/kg |
| Scan duration | 15 minutes of scanning |
| Image artifact (3 tesla, gradient echo, pulse sequence) | The image artifact extends approximately 5 mm from both the device, both inside and outside the device lumen. |
| Time (post-implant) to safely scan | No restrictions listed 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 markets where this product is available. RXOnly
INDICATIONS FOR USE: The GORE® TIGRIS® Vascular Stent is intended to improve luminal diameter in patients with symptomatic de-novo or restenotic lesions or occlusions in the native superficial femoral artery (SFA) and proximal popliteal artery (PPA) with reference vessel diameters ranging from 4.0 - 6.5 mm and lesion lengths up to 240 mm.
CONTRAINDICATIONS: The GORE® TIGRIS® Vascular Stent is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. The GORE® TIGRIS® Vascular Stent is contraindicated in patients with contraindication to antiplatelet and/or anticoagulation therapy. DO NOT use the GORE® TIGRIS® Vascular Stent in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.