MRI Information - US

iStent^® (Models GTS100L and GTS100R) – 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.

iStent inject^® (Model (G2-M-IS) – MRI Safety Information

Non-clinical testing has demonstrated that the iStent inject^® Trabecular Micro-Bypass Stent Model G2-M-IS 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 inject^® Trabecular Micro-Bypass Stent Model G2-M-IS 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.

iStent inject^® W (Model (G2-W) – MRI Safety Information

Non-clinical testing has demonstrated that the iStent inject^® W Trabecular Micro-Bypass System Model G2-W 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

Under the scan conditions defined above, the iStent inject^® W Trabecular Micro-Bypass System Model G2-W 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.

iStent infinite^® (Model (iS3) – MRI Safety Information

Non-clinical testing has demonstrated that the iStent infinite^® Trabecular Micro-Bypass System (Model iS3) 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

Under the scan conditions defined above, the iStent infinite^® Trabecular Micro-Bypass System (Model iS3) 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.