HydroFill™ Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
MRI Safety Information
Non-clinical testing and MRI simulations were performed to evaluate the entire family (i.e., available diameters and lengths) of the MicroPlex1™ Coil System (MCS). Non-clinical testing demonstrated that the entire family of these embolization coils (see table below) is MR Conditional. A patient with an implant from this family can be scanned safely in an MR system under the following conditions:
- Static magnetic field of 1.5-Tesla and 3-Tesla, only
- Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
-Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the MicroPlex™ Coil System (MCS) is expected to produce a maximum temperature rise of 2.3˚C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the MicroPlex™ Coil System (MCS), Cosmos™ 18 extends approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.
Table. Embolization coils covered by the MRI Safety Information.
MicroPlex™ Coil System (MCS)(Embolization Coil)
HydroCoil™ Embolic System (HES)(Embolization Coil)
1Test Report TR10-016 on file at Terumo Neuro.