MRI Safety

The B-Clamp®  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 B-Clamp® 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 B-Clamp® 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 B-Clamp®. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary.