DFU & MRI Information

Directions for Use


MRI Safety Information

Static Magnetic field of 3 Tesla or less
Non-clinical testing has demonstrated that the iStent inject Trabecular Micro-Bypass System, 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 System, 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.

Static magnetic field of 7-Tesla, ONLY:
Non-clinical testing demonstrated that the iStent inject Trabecular Micro-Bypass System, Model G2-M-IS is MR Conditional. A patient with this device can be safely scanned immediately after implantation in an MR system meeting the following conditions:

  • Static magnetic field of 7-Tesla, ONLY
  • Maximum spatial gradient magnetic field of 10,000-gauss/cm (extrapolated) or less
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
  • First Level Controlled Operating Mode of operation for the MR system
  • Use of a transmit/receive RF head coil, ONLY

MRI-Related Heating
In non-clinical testing, the device produced a temperature rise of 0.4°C during MRI performed for 15-minutes of scanning (i.e., per pulse sequence) in a 7-Tesla/298-MHz MR system (Philips Acheiva, Philips Healthcare, Cleveland, OH) using at transmit/receive RF head coil.

MR system reported, whole body averaged:

  • SAR < 1-W/kg Artifact Information

In non-clinical testing, the image artifact caused by the device extends approximately 23-mm from this device when imaged using a gradient echo pulse sequence and a 7-Tesla MR system.