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                                            Safety Information Article
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       Spinal Cord Stimulation (SCS), Stimwave Technologies, Inc., Freedom Spinal Cord Stimulator (SCS) System, Models: FRT4-A001, FRE4-A001 

Spinal Cord Stimulation, Stimwave Technologies, Inc.

Freedom Spinal Cord Stimulator (SCS) System

Models: FRT4-A001, FRE4-A001

The Freedom Spinal Cord Stimulator (SCS) System (spinal cord stimulation system) (Stimwave Technologies, Inc.) is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom SCS System features leads that are MR Conditional for full body MR procedures at 1.5- and 3-T.

Magnetic Resonance Imaging (MRI) – An MRI examination may be safely performed under specific conditions. Refer to the Product Safety Guide for specific MRI guidelines, www.stimwave.com

[MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.]

References

Shellock FG, Audet-Griffin A. Evaluation of magnetic resonance imaging issues for a wirelessly-powered lead used for epidural, spinal cord stimulation. Neuromodulation 2014;17:334-339.

www.stimwave.com



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