Spine

FDA Approves Injectable Device for Back, Leg Pain

By Susan Jeffrey
Medscape Medical News

 

Dec. 4, 2014 — The FDA has approved an injectable microchip nerve-stimulation device for the relief of ongoing back and leg pain.

The Stimwave Freedom Spinal Cord Stimulation (SCS) system is expected to be available in the United States next January, the company, Stimwave Technologies Inc., said in a statement.

The device is already being sold in Europe to treat back and leg pain.

Developed by scientists and engineers led by co-inventor and company chairman Laura Tyler Perryman, the technology involves a tiny injectable microchip device that delivers small energy pulses to electrodes near surrounding nerves, the statement says. It “trigger[s] a reaction that enables the brain to remap specific pain signals, thus providing pain relief. Historically with SCS, dependency on pain medications can be drastically reduced or even eliminated.”

“This technology is no longer an academic-type science experiment, but a real, viable innovation that can immediately start being utilized by patients in pain,” Perryman says in the statement.

Neuromodulation, or nerve stimulation, has been an FDA-approved treatment for back and leg pain for more than 30 years. The difference for this new device is the small size, the release says. Measuring between 2 cm and 11 cm, it can be implanted through a standard needle, making that process shorter and less expensive.

It is also wireless, getting rid of the need for wires to be connected to a power source. These external wires are the root of more than 80% of complications linked to this type of therapy, the company says.

The device has no internal batteries or other toxic materials, and is fixed in place by an anchor to limit its movement. It is a “permanent, long-term implant,” the release says. “It naturally stays ‘in line’ with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.”

People can also get a whole-body MRI scan without removing the device, “which is unique in the industry,” the company says.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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6 Comments

  1. If I understand this article correctly, the pain is simply re-routed somewhere else. The brain will no longer focus on the back or spine pain, but instead focus on the pain…where exactly?

  2. I recently was given the trial spinal cord stimulator and it was considered a success because I had greater than 50% improved pain relief. I wore it for 5 days and missed it terribly once it was out. I’ve been approved to get the stimulator that lasts in the body, with a rechargeable battery, for 8-9 years.

    I read this article about the “new” microchip stimulator and even discussed it with my doctor in great length and detail. He was very intrigued by it and passed along the website(s) to his fellow colleagues. I’m thrilled that he’s so interested because I would much rather get this microchip injected and anchored in place and be done, rather than have incisions open again with long leads fed up my back (and he said I have substantial amounts of scar tissue). The leads are attached to the battery pack that is also inserted into a pouch they cut I to your hip/buttock are…and that’s where it stays.

    Here is my ONLY question that I can’t seem to get help answering. My trial stimulator had to be turned on and off, adjust different outputs into leads in different areas of my back, and even simply choose which lead or leads I wanted working at the appropriate time for successful pain relief. The only way to do any of that was to place the remote over the battery pack (just right or it wouldn’t sync correctly). That was with my trial, now with that permanent scs they implant the battery and it’s a little tricky from what I hear, lining up the remote with your now internal battery pack. Maybe going through skin thickness makes it more difficult, I don’t know. My question is, with the new microchip stimulator, it says there’s no need for batteries, internal or external. The microchip is anchored in place where best results would be given and there’s no wires or leads running though your body to attach to anything, especially not a battery pack.

    How does that work? Here has to be a way for the remote to work the microchip. I can’t find anything else online. What I pictured it that the patient would need to wear a belt, perhaps, to keep the remote over the microchip…or how else will it get a power source? I’m so confused and I have my team of 3 surgeons looking Into. it as well. He doesn’t want me to be the first person given it in the USA but he also thinks it’s worth me waiting a few weeks or a month so we can get as much info as we can.

    Anyone have any idea, suggestions, concerns to share? I would greatly appreciate it. This is a scary thing for me as a 45 yr old woman to do. I just want my quality of life back so my children can have ME back 🙂 That’s all I’ve ever wanted, that and just a little more pain relief.

    Thanks so much in advance for reading. Sorry it’s so long.
    Amy (Austin, Texas)

  3. I read somewhere that the battery on the antenna had to be charged daily but like you I’m having trouble finding the website that had the information. I’ll continue to look and update with site once I find it.

  4. I would love to see this in Stimulator used for Trigeminal and Occipital Neuralgias. Sometimes placement directly on the facial nerves might be better the the c2-c3 as previous coverage was not always possible. We as patients need this technology as our pain management is being taken away constantly and our suffering is excruciating and vast with no cure on sight.

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