MRI Information - AUS

iStent inject® (Model (G2-M-IS) – 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.

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

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.

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.

PRESERFLO® (Model GLT-001) – MRI Safety Information (FOR AUSTRALIA)

The PRESERFLO® MicroShunt is MR Safe.

The PRESERFLO® MicroShunt must not come in direct contact with topical treatments (e.g. ointments) that contain petrolatum (petroleum jelly).

PRESERFLO® (Model GLT-101) – MRI Safety Information (FOR NEW ZEALAND)

EN The PRESERFLO® MicroShunt is MR Safe

FR The PRESERFLO® MicroShunt is MR SÉCURITAIRE.

iStent infinite® (Model (iS3) – MRI Safety Information (NEW ZEALAND ONLY)

Static magnetic field of 3-Tesla or less:

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.

Static magnetic field of 7-Tesla, ONLY:

Non-clinical testing demonstrated that the iStent infinite® Trabecular Micro-Bypass Stent (Model iS3) 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.

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