Non-clinical testing has demonstrated the AndraStent Aortic and Covered AndraStent Aortic, represented by the Covered AndraStent ASC57XXL are MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

• • • • • Static magnetic field of 3 Tesla, with
        • Maximum spatial field gradient of 7,200 G/cm (72 T/m)
        • Maximum force product of 132,000,000 G2/cm (132 T2/m)
        • Theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the stent is expected to produce a maximum temperature rise of less than 3.2 °C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of around 1.0 °C (2 W/kg, 3 Tesla) after 15 minutes of continuous scanning.

In non-clinical testing, the image artefact caused by the device extends approximately 17.5 mm from the stent when imaged with a gradient echo pulse sequence and a 3 Tesla MR system