Connect
Has Anybody Tried the Setpoint Medical Vagus Nerve RA Device Installed
The SetPoint System is an implantable neuroimmune modulation device for Rheumatoid Arthritis that stimulates the left vagus nerve to activate innate anti-inflammatory pathways. Its been approved by the FDA last year after completion of randomized trial that required at least a 20% reduction in inflammation symptoms. So far, it is in Ascension Dell Seton Medical Center in Texas, Rush University Medical Center in Chicago and Northwell’s North Shore University Hospital on Long Island, NY. I heard in January that Mayo in Minnesota was evaluating the device. I am hoping that it expands into the Mayo in Florida so my wife can get it but have not heard about experiences from patients except the few on the Setpoint Medical web site.
Like
Helpful
HugInterested in more discussions like this? Go to the Autoimmune Diseases Support Group.
Connect
Quite interested as well.
-
Like -
Helpful -
Hug
1 ReactionMy rheumatologist has recommended this device for me. She said it was FDA approved, which doesn’t necessarily make me trust it.
She also said she was involved with trialing the device. It is supposed to be available in my state later this summer. It was described as a small device the size of a large capsule that would be implanted in my neck and will stimulate the vagas nerve for just 30 seconds a day.
I am unable to take biologic drugs or other useful immunosuppressants. This would supposedly decrease the inflammation without the use of medication. She asked me to review the research and the device information and return this summer to discuss. This platform is the only other source I have seen this brought up other than my rheumatologist. I will be following the information. At this time, I am not personally ready to jump on board just yet.
-
Like -
Helpful -
Hug
2 Reactions@gypsyblue
what state are you in?
very interesting. 25 years with RA and lots of trouble tolerating meds. Retinal toxicity with Plaquenil, allergic to MTX, bad reaction to my first biologic infusion. seems like I'd be a good candidate from something like this.
Approved
I live in NYC and am scheduled to have the device put in on 8/26. Honestly I'm having doubts due to the fact that I'm a working professional singer. I can't seem to find out if ANY pro singers have had this done. I would be devastated if it altered my voice. My vocal doctor said proceed with caution. He's seen vocal paralysis with the old device that activates all day. This one only 60 seconds a day. The surgeon who is implanting mine was involved in the trials and has put in over 30. Thoughts?
-
Like -
Helpful -
Hug
1 Reaction@jaynel Welcome to Mayo Clinic Connect. Any members who have heard of this device will probably respond to your request for information. Maybe, in the meantime, you could try an internet search to see if there is any news or talk about it.
-
Like -
Helpful -
Hug
1 Reaction@jaynel Hi. You might try contacting Johns Hopkins for information. It is part of their treatment protocol.
@gypsyblue I can’t help you with regard to efficacy in autoimmune disease, but my son has a vagus nerve stimulator implanted to help with epilepsy. It’s implanted in his chest wall with the wires running up through his neck, connecting to his vagus nerve.
The only side effect he’s had is that when it goes off it changes the tone of his voice and he can’t drink for those seconds that the device is deploying. His goes off for 30 seconds every 90 seconds throughout the day. He’s 27 and he just had his 3rd device put in, so on average his are lasting about 5 years.
If you are thinking about it, perhaps confirm the following:
1. 30 seconds ONCE a day doesn’t sound like a lot - ask how many times a day it will be scheduled to go off per day.
2. Double check whether the device is implanted in the neck or chest wall.
3. Find out how long they think the device will last before you would need a revision surgery to replace the device.
All my doctors are at Northwell Health on Long Island where the research was conducted. Unfortunately, I wasn’t a good candidate for the trial.
My son is finally seizure-free with the neurostimulator and able to drive for the first time in his life so it’s been life-changing for him.
Best of luck with whatever you decide!
-
Like -
Helpful -
Hug
1 ReactionMy son has a regular Medtronic neurostimulator that goes off for 30 seconds every 90 seconds 24/7 (epilepsy).
It does change his voice for those 30 seconds. His voice drops to a whisper but returns as soon as the stimulation stops. He has had his for 11 years. It was much better in the beginning before they cranked him to one of the maximum settings, but he was still having breakthrough seizures - so his choice was no seizures + driving vs. the voice trade off. It has not caused permanent paralysis, but I can definitely understand your concern if you sing.
Perhaps find a Facebook group for your condition, even if you post anonymously or under a nickname, and ask if anyone has had the Setpoint device implanted and ask whether or not anyone has had any voice issues with it post operatively.
Good luck!!