Non-clinical testing demonstrated that a representative steel suture is MR Conditional. A patient with this suture can be scanned safely immediately after
placement of the suture under the following conditions:
- Static magnetic field of 1.5T and 3.0T
- Maximum spatial gradient magnetic field of 2360-Gauss/cm
- Normal operating mode of operation for the MRI system (whole body averaged SAR, 2-W/kg) for 15 minutes of scanning, per pulse sequence
Under the scan conditions defined above, the steel suture is expected to produce a maximum temperature rise of less than 9.4 C after 15 minutes of
continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 24 mm from the titanium clip when imaged with a gradient echo
pulse sequence and a 3.0T MRI system.