MRI Safety Information

Non-clinical testing demonstrated that the AneuFix polymer implant is MR Conditional. A patient treated with AneuFix can be scanned safely in an MR system under the following conditions:

• Static magnetic field of 1.5-Tesla or 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 for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode.

Under the scan conditions defined, the AneuFix implant is expected to produce a maximum temperature rise of 4°C after 15-minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by the AneuFix implant extends approximately 2 mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.