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 TrelliX Embolic Coil System, All Versions

Shape Memory Medical, Inc.,

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


1.5, 3
Conditional 8
Coils, Filters, Stents, and Grafts
Coils, Filters, Stents, and Grafts

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