MRI Safety Information
Non-clinical testing and MRI simulations were performed to evaluate the LOBO Vascular Occlusion Device. Non-clinical testing demonstrated that this product is MR Conditional. A patient with an implant 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 2,000-gauss/cm (20-T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg in the Normal Operating Mode
Under the scan conditions defined, an implant from the LOBO Vascular Occlusion Device is expected to produce a maximum temperature rise of 2˚C after 15-minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the implant from the LOBO Vascular Occlusion Device extends approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.