Non-clinical testing has demonstrated both Aorfix™ and Altura™ products can be scanned safely in an MR system. Full details taken from our product IFUs is noted below.

Aorfix™

Please refer to section 10.4 of the Aorfix IFU

Non-clinical testing has demonstrated that the Aorfix™ Stent Graft implants are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static Magnetic Field
  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
  • Maximum spatial gradient field less than or equal to 10 T/m
  • Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of:
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T
    • 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T

Altura™

Please refer to section 4.7 of the Altura IFU

Non-clinical testing has demonstrated that the Altura Endograft System endografts are MR Conditional. Patients with this device can be scanned safely in an MR system meeting the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
  • Maximum spatial gradient field less than or equal to 30 T/m (3000 gauss/cm)
  • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the Altura Endograft System endografts are expected to produce a maximum temperature rise of 6.47°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 11 mm for the Altura Endograft System endografts when imaged with a gradient echo or spin echo pulse sequence in a 3.0 Tesla MRI system.

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