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Prescribing Information: StimTrial | StimRouter | TalisMann
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LBL-000739-Rev.-B-TalisMann-Clinician-Guide (1)

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Indications for Use
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Do not use the StimRouter Neuromodulation System in users who have an implanted demand cardiac pacemaker, implanted cardioverter defibrillator (ICD), or other implanted active device, or who have bleeding disorders that cannot be stopped in advance of the StimRouter implantation procedure. Do not use the system where a metallic implant or a cancerous lesion is present in the immediate implant area. Effects of stimulation during pregnancy are not known. StimRouter is capable of producing skin irritation and muscle ache in the area of stimulation.

Full prescribing information can be found in the StimRouter Clinician Guide, or Customer Service at 888-453-2136.

The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.

Full prescribing information can be found in the TalisMann Clinician Guide, or Customer Service at 888-453-2136.

The StimTrial System is indicated for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for the StimRouter Neuromodulation System’s permanent (long term) implant indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain in the craniofacial region.

Full prescribing information can be found in the StimTrial Clinician Guide, or Customer Service at 888-453-2136.

Contraindications:
Do not use StimTrial, StimRouter, or TalisMann in users who have an implanted demand cardiac pacemaker, implanted cardioverter defibrillator (ICD), or other implanted active device, or who have bleeding disorders that cannot be stopped in advance of the implantation procedure. Do not use the system where a metallic implant or a cancerous lesion is present in the immediate implant area. Effects of stimulation during pregnancy are not known. StimRouter, TalisMann and StimTrial are capable of producing skin irritation and muscle ache in the area of stimulation.

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StimRouter is a registered trademark and TalisMann is a trademark of Bioness Inc.

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