StimRouter (Bioness)

One of Four Peripheral Nerve Stimulators (PNS)

Adults suffering with chronic pain can receive long-term pain relief with the StimRouter PNS. There are several new technological advancements to improve the user experience:

Mobile application for iPhone and Android to replace the handheld Patient Programmer
Buttons on the E-EFC unit to manually turn the system on, off, up, and down
Water resistance (IP68 rating) to improve system durability
Improved battery, with longer battery life than the existing StimRouter
Smallest external device on the market.

Trial Period: There is no trial period for StimRouter which disappointed us. The first procedure is the only one and is permanent. Its two competitors with permanent implants, Curonix and Nalu, each have a 7-day trial period. We feel this needs to change now. We have written to Bioventus about this issue. They are putting profit before people.

The StimRouter is MR Conditional at 1.5T and 3.0T (with the external transmitter removed). The entire device should lie outside the physical limits of the RF transmit coil used (body, head, knee, etc.

Adhesive or Wearable to attach external transmitter to body?

Adhesive

The EPT or, External Pulse Transmitter is the “brains” of the StimRouter System, sending electrical signals through the skin to the implanted lead. The EPT can store up to eight custom stimulation programs and provide patients with a variety of treatment options depending on their activity and/or pain level. The EPT attaches to the disposable user patch (two black adhesive areas), transmitting stimulation through the patch’s gel electrodes on its other side.

The external pulse generator/transmitter and the battery are again housed together and snap on the conductive gel pad worn on the skin. This generates the stimulation signal and transmits the signal through the electrode to the lead. The electric arc is completed through the conductive gel pad.

Photo 1 - Woman 5'3" wearing StimRouter. It would be worn lower after implant to be as close as possible

to lead receiver at the end of the lead - the tined end with anchor to prevent migration.

Photo 2 - StimRouter external system: topside of EPT (External Pulse Transmitter), bottom side of Electrode Strip which clips onto Disposable Adhesive with two areas of block gel.

Photo 3 - The backside of the disposable adhesive strip which clips onto the Electrode strip.

Photo 4 - Diagram of electrode strip which clips onto disposable adhesive strip to attach to body, the lead with 3 electrodes and anchor to prevent lead migration, the ETP external device, and the hand-held paitent programmer.

Photo 5 - In person photo of lead which will be implanted next to pudendal nerve before it divides into its three branch so that all chronic pain signals will be interrupted by stimulator. Photo shows real life anchor that will prevent lead from migrating or falling out as has happened with a competitor.

Photo 6 - Figure (or diagram) from StimRouter manual showing how system works with the Receive End of the lead to be placed as close to the pudendal nerve before it divides as possible.

Anecdote: One of our PN Facebook members recently had the Stimrouter implanted. The prcedure was extremely painful as they doctor stuck her with the introducer (a large, 13-gauge needle) many times as he had only implanted a few for pudendal neuralgia and like 99% of doctors didn't think he needed to train under an experienced one. She endured the pain because she had waiting so long for a PNS to hopefully stop the chronic pain of pudendal neuralgia. This should never be allowed. The patient, her/his safety and welfare should be priority number one, but doctors don't want to "waste time" training, as one doctor in Wisconson recently told me. He meant its time away from making money even if he's not truly competent in the procedure.

U.S. States do not require doctors to train in person under an experienced doctor on living people to be accredited to implant any PNS. They only need to attend a lecture with a slide presentation. Doctors can practice on cadavers if they choose. This is clearly medically unethical. PNA will write to the FDA and medical device companies - and elected representatives to change this medically unacceptable subpar requirement to implant a device into a living person.

We suspect that for almost all U.S. doctors, you will be the FIRST patient for PN implant (guinea pig) for, regardless of the brand the doctor uses.

Doctor Training for PNS

U.S. states do not require doctors to train in person under an experienced doctor on living people to be accredited to implant any PNS. They only need to attend a lecture with a slide presentation. Doctors can practice on cadavers if they choose. We feel this is clearly medically unethical when it comes to patient safety and the laws need to change now.

We suspect that for almost all U.S. doctors, you will be the FIRST patient for PN implant (guinea pig) for, regardless of the brand the doctor uses.

Twilight Sedation for PNS

Doctors WILL give twilight sedation during the introducer portion of the implantation. It is usually a mixer of fentanyl and midazolam. You will be awake, but the drugs will help you to not remember and will reduce the pain. This is NOT like sedation with propofol where you are unconscious and feel no pain. This is used for Botox injections.

Second Opinion

The doctor can walk you up once the lead is in place (no more sticking with large needles) to test how it's working. We highly suggest this, but it's up to you and your pain mgmt. physician. Some doctors will refuse twilight sedation before any discussion. You must decide what is best for you. Second opinions, even if they are via phone or Zoom, are always a good idea especially t since you will wear this PNS for the rest of your life, hopefully a new and pain-free life, but it is a serious decision.

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Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

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