TrelliX Embolic Coil System, All Versions

Shape Memory Medical, Inc., www.shapemem.com

MRI Safety Information

Non-clinical testing and MRI simulations were performed to evaluate the entire family (i.e., available diameters and lengths) of the TrelliX Embolic Coil System. Non-clinical testing demonstrated that the entire family of these embolization coils 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 or 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) ofm2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode