MRI Compatibility

Non-clinical testing has demonstrated that the Vertiflex Superion® IDS is MR Conditional. It can be scanned safely under the following conditions:

  • Static magnetic field of 1.5-Tesla (1.5 T) or 3.0-Tesla (3.0 T).
  • Spatial gradient field of up to:
    • 7,480 G/cm (74.80 T/m) for 1.5 T systems.
    • 3,740 G/cm (37.40 T/m) for 3.0 T systems.
  • Maximum whole body averaged 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.

1.5T RF heating

In non-clinical testing with body coil excitation, the Vertiflex Superion® IDS produced a temperature rise of less than 4.0 ºC at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg, as assessed by calorimetry for 15 minutes of scanning in a 1.5 T Siemens Espree (MRC30732) MR scanner with SYNGO MR B17 software.

3.0T RF heating

In non-clinical testing with body coil excitation, the Vertiflex Superion® IDS produced a temperature rise of less than 5.0 ºC at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg, as assessed by calorimetry for 15 minutes of scanning in a 3.0 T Siemens Trio (MRC20587) MR scanner with SYNGO MR A30 4VA30A software.

Caution: The RF heating behavior does not scale with static field strength. Devices that do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

MR Artifact

In testing with gradient-echo sequencing, the shape of the image artifact follows the approximate contour of the device and extends radially up to 2.6 cm from the implant.