MRI Conditionality

Non-clinical testing has demonstrated that the Vertiflex™ Procedure – Superion™ Indirect Decompression System 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.

No fragments of an Instrument used to implant the Superion IDS are retained in the patient’s body.

WARNING: Serious personal injury or death could occur if an MRI is performed on a patient with retained fragments of an Instrument used to implant the Superion IDS.

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.