MRI Safety

The Bariclip  was determined to be MR Conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International.

Non-clinical testing demonstrated that the BariClip is MR Conditional. A patient with this implant can be scanned safely immediately after placement under the following conditions:

• Static magnetic field of 3-Tesla or 1.5-Tesla.

• Spatial gradient magnetic field of 3000-Gauss/cm or less.

• Maximum MR System reported whole-body averaged specific absorption rate (SAR) of 2-W/kg in the normal operating mode.

In non-clinical testing, the BariClip produced a temperature rise of less than 4°C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of continuous MR scanning in a 3-Tesla MR system using a transmit/receive body coil (Signa HDx, Software 15/LX/MR, General Electric Healthcare, Milwaukee, WI).

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Bariclip. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary.