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Real members of myRAteam have posted questions and answers that support our community guidelines, and should not be taken as medical advice. Looking for the latest medically reviewed content by doctors and experts? Visit our resource section.

Question on this FDA approved implant device called the SetPoint System?

A myRAteam Member asked a question in Natural Remedies group 💭
Plano, TX

I have been diagnosed with RA for almost 3 years now, but suspect I had it a long time before. I just read about PMRA and wonder if I don’t have both. I have tried all sorts of the DMARDs meds and infusion and my body rejects them all. My doctor suggested “SetPoint” system. They implant a very small devise in the neck to activate the body’s natural immune pathways that reduces inflammation and restores balance without immune compromising side effects. I was wondering if anybody has had it… read more

October 5
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myRAteam

The SetPoint System is a genuinely exciting development, especially for someone who has struggled to tolerate DMARDs and biologics. Your doctor's suggestion makes a lot of sense given your treatment history.

Here's what is known about how it works:

- It's a small implant, roughly the size of a vitamin tablet, placed on the Show Full Answer

The SetPoint System is a genuinely exciting development, especially for someone who has struggled to tolerate DMARDs and biologics. Your doctor's suggestion makes a lot of sense given your treatment history.

Here's what is known about how it works:

- It's a small implant, roughly the size of a vitamin tablet, placed on the vagus nerve in the neck during an outpatient procedure
- It delivers just 60 seconds of gentle electrical stimulation per day
- It works by activating the body's natural anti-inflammatory pathways rather than suppressing the immune system broadly
- It's specifically approved for adults with moderate-to-severe RA who haven't responded well to biologics or JAK inhibitors The clinical trial results were encouraging. Nearly half of participants achieved low disease activity or remission after 12 months, and 75% were able to stay off advanced medications for a full year while using the device.

In terms of side effects, around 5% experienced hoarseness, and just under 2% had serious side effects, mostly in the first three months, related to the surgical procedure itself, such as pain or infection at the implant site.

It's worth noting that the SetPoint System is currently rolling out in select U.S. cities in 2025, with wider availability expected in 2026, so availability may vary depending on location.

Since this is a very new device, there may not be many myRAteam members who have personal experience with it yet — but it's absolutely worth raising specific questions and concerns with your rheumatologist before committing. You're asking exactly the right questions!

October 5
A myRAteam Member

How exciting! Yes, thank you for the updates! Looking forward to hearing how it works out!

5 days ago
A myRAteam Member

I have decided to go ahead and I am scheduled to meet on November 11 with the surgeon McKinney Texas. Close to where I live. I am hoping to have it implanted before the holidays. Will give you all updates. Diana K 🥰

5 days ago
A myRAteam Member

I inquired with my rheumy and she wasn't familiar with it but suspected I would have to go thru neurology to get this approved. Has that been your experience?

5 days ago
A myRAteam Member

I’ve investigated the set point system. As soon as it’s available in my area I will be checking it out

October 10

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