DFU & MRI Information

Directions for Use – Australia

iStent inject® DFU iStent® DFU iStent inject® W DFU
iStent inject® DFU iStent® DFU

MRI Safety Information

Static magnetic field of 3-Tesla or less:

Non-clinical testing has demonstrated that the iStent inject® (Model G2-M-IS) is MR-Conditional. A patient with this device can be scanned safely immediately after implantation in an MR system meeting the following conditions:

  • Static magnetic field: 3-Tesla or less
  • Maximum spatial magnetic field of 4,000 gauss/cm (40 T/m) (extrapolated)
  • 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 (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the device extends less than 15 mm from the device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

Static magnetic field of 7-Tesla, ONLY:

Non-clinical testing 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 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.

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.

MRI Safety Information – iStent inject® W

Static magnetic field of 3-Tesla or less:

Non-clinical testing has demonstrated that the iStent inject® W (Model G2-W) is MR Conditional. A patient with this device can be scanned safely immediately after implantation in an MR system meeting the following conditions:

  • Static magnetic field: 3-Tesla or less
  • Maximum spatial magnetic field of 4,000 gauss/cm (40 T/m) (extrapolated)
  • 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® W Trabecular Micro-Bypass Stent (Model G2-W is not expected to produce a clinically significant temperature rise after 15 minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the device extends less than 15 mm from the device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

Static magnetic field of 7-Tesla, ONLY:

Non-clinical testing demonstrated that the iStent inject® W Trabecular Micro-Bypass Stent (Model G2-W) 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.

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