DFU & MRI Information
Directions for Use
MRI Safety Information
Non-clinical testing has demonstrated that the iStent Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 3T or less
- Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the iStent Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is not expected to produce a clinically significant temperature rise after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends less than 15 mm from the device when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.