Curonix Stimwave Freedom

One of Four Peripheral Nerve Stimulators (PNS)

A. The Freedom-4 PNS Stimulator can be scanned safely under the following conditions.

Static magnetic field of 1.5-Tesla or 3-Tesla. Maximum spatial gradient field of 30 T/m (3,000 Gauss/cm). No restrictions on position of the Freedom-4 Stimulator with respect to MR system bore or body part undergoing MR imaging.

Most doctors will use the Freedom-4 for pudendal neuralgia.

B. The Freedom-8A PNS Stimulator - not used for pudendal nerve.

Trial Period: Curonix, just as Nalu, has a 7-day trial period per the FDA.

Photos from Curonix website

Electrodes Array

Number of Independent Channels: 2

Photos from Curonix manual

In person photo taken by one of us of wearable antenna (large and small)

assembly and the 4 and 8 electrodes. Again, only 4-lead used for PN.

Adhesive or Wearable to attach external transmitter to body?

Wearable

1st photo - Taken in person by one of us of woman 5'3" with the XS wearable belt a pudendal neuralgia patient would use. 70% of people with PN are women and the average woman is 5'4".

2nd photo - Taken by one of us of the large and the small blue antenna, one which would be under the wearable WITH the black transmitter ("the assembly"). We hope the small antenna will work for PN. Curonix.always posts the small antenna in official photos. We took the picture of the large and small held in back of a PN patient.

3rd photo - From Curonix website of the small antenna and black transmitter which are worn under the wearable.

We have written a letter to Curonix asking them to create an adhesive option to put on the back of the device as another option as this wearable is large.

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 with an excellent outcome, but you should be comfortable with the doctor and how they intend to conduct the prcoedure.

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Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

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