Answers about StimRouter PNS

How do I know if StimRouter will work for me?

StimRouter is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin. Your clinician is the best person to describe how StimRouter compares to other possible pain management options.

 

Are there any contraindications?

Yes. StimRouter is contraindicated for patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or metallic implant in the immediate area intended for implant. A risk/benefit determination should be performed before using the StimRouter system for:

  • Patients exposed to diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used on patients who have a StimRouter Neuromodulation System. The energy generated by diathermy can be transferred through the StimRouter system components, causing tissue damage at the lead site and potentially resulting in severe injury. Diathermy may also damage the StimRouter system components, resulting in loss of therapy. Injury or damage can occur during diathermy treatment whether neurostimulation is turned on or off. All patients are advised to inform their health-care professionals that they should not be exposed to diathermy.
  • Patients exposed to therapeutic ultrasound.
  • Patients who are unable to operate the StimRouter system.
  • Patients who are high surgical risks or poor surgical candidates in general.
  • Patients who have a cancerous lesion present near the target stimulation point or near to where the StimRouter Electrode will adhere.
  • Patients with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure.
  • Do not use the transmit/receive RF head coil if the StimRouter Lead is implanted above the shoulder.

Can I get an MRI with the StimRouter System with physician approval?

Yes. The implanted StimRouter Lead is 1.5 Tesla and 3 Tesla MR Conditional. Patients with an implanted lead can be scanned safely under certain MR conditions. All external components of the System must be removed before the patient is allowed into the MRI environment.

What are the risks related to the StimRouter System?

Suboptimal lead placement may necessitate therapeutic adjustment and/or lead explant. Nerve injury is possible, although unlikely. Possible surgical complications include infection, cellulitis, abscess, fever, sepsis, bleeding and temporary pain at the implant site.

How long should the implanted lead stay in the body?

The StimRouter lead is designed to be a long-term implant. Your physician will discuss your appropriate individual treatment plan.

What can I expect during and after the procedure?

The surgical procedure is a simple procedure performed under local anesthesia. You will be awake during the implant in order to provide feedback to the implanting physician regarding the effectiveness of the stimulation. After the small incisions heal 2 to 3 weeks later, your physician will program your external pulse transmitter and teach you how to control your pain with your patient programmer.

Does StimRouter require a prescription?

Yes. In order to acquire StimRouter, a prescription from your physician is required.

How often will the StimRouter System need to be programmed after initial set up?

Your StimRouter external pulse transmitter will initially be programmed with up to eight different stimulation programs from which you will be able to select, turn off/on and increase or decrease the stimulation intensity. If the programs are no longer providing appropriate pain relief, you may contact your physician to be reprogrammed.

Does my insurance cover the StimRouter System?

The StimRouter System is billed by your healthcare professional and often reimbursed if it is deemed medically necessary. While we cannot guarantee insurance reimbursement for StimRouter, your health insurance plan may cover some or all of the cost.

Does StimRouter come with a warranty?

Yes. The StimRouter System has a one-year limited warranty.

How can I find out if I am a candidate for StimRouter?

You may contact a Bioness Representative to help you get started by calling (800) 211-9136 option 2.

Do I need to order ongoing supplies?

Yes. The disposables required for the ongoing use of the StimRouter are called Gel Electrode Patches and should be changed every 2 to 4 days depending on use. Order online or contact Bioness Client Relations Department at (800) 211-9136 option 2.

Who do I contact if I need help with my StimRouter System?

For any questions regarding StimRouter trouble-shooting please contact our Technical Support Team at (800) 211-9136 option 3.

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StimRouter Clinical Support

Monday – Friday, 8 am – 5 pm PST

800.211.9136, option 3

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Rx Only. 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. StimRouter is contraindicated in patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or metallic implant in the immediate area intended for implant. For complete instructions for use, storage, warnings, indications, contraindications, precautions, adverse reactions and disclaimer of warranties, please refer to the insert accompanying each product or online at www.stimrouter.com.