Magnetic Resonance Imaging (MRI) Guidelines for the Axonics SNM System

Implantable components of the Axonics SNM System have conditional labeling in Europe for 1.5T and 3T MRI head scans under specified conditions. The implanted components of the Axonics SNM System include the Axonics Neurostimulator (Model 1101) and Tined Lead (Model 1201).

Please read the Axonics MRI conditional Guidelines carefully before use to learn about the conditions, potential risks, precautions, and instructions on using MRI with the Axonics SNM System. MRI scans performed outside the guidelines may result in the interaction of MRI fields with implanted devices, potentially damaging the implanted device and injuring the patient.

These guidelines are related only to the use of a transmit/receive radio frequency (RF) head coil of a 1.5T and 3T horizontal closed-bore MRI system for patients implanted with the Axonics SNM System.

Please note that the external components of the Axonics SNM System including the patient Remote Control, Charging System and Clinician Programmer should not be brought into the MRI room.