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SetPoint System · Neuroimmune Modulation

A new way to treat rheumatoid arthritis — without another drug.

The SetPoint System is a small implanted device that treats RA by gently stimulating the vagus nerve — using your body's own inflammation "off switch" instead of suppressing your immune system. FDA-approved in 2025, it is the first therapy of its kind. Synergy is one of the first practices in the region to offer it, and we manage your care from candidacy through activation and long-term monitoring.

How it works

Your vagus nerve is part of a natural circuit that helps regulate inflammation. When it is stimulated, it signals the spleen to reduce production of the inflammatory proteins — like TNF — that drive rheumatoid arthritis. Biologic drugs block those proteins from the outside. The SetPoint System instead activates your body's own pathway to turn the inflammation down.

The device sits on the vagus nerve in the neck and delivers about one minute of stimulation a day, automatically. There is nothing to take, inject, or infuse — and, importantly, it does this without the broad immune suppression that biologics and JAK inhibitors rely on.

Uses a natural circuit

Activates the body's own anti-inflammatory pathway

One minute a day

Automatic — nothing to take, inject, or infuse

No immune suppression

No routine labs, no ongoing infection monitoring

Discreet once healed

Not visible and can't be felt from the outside

Is this an option for me?

The SetPoint System is approved for adults with moderate-to-severe rheumatoid arthritis who have already tried at least one advanced medication. It is not for everyone — and the honest answer to whether it fits your situation is a conversation, not a checklist. Here is the starting point.

Worth considering if

  • You have moderate-to-severe RA and have tried at least one biologic or JAK inhibitor
  • You need to avoid immune-suppressing drugs — for example, a history of cancer or recurrent serious infections
  • You are worn out by injections or infusions and want a lower day-to-day burden
  • You prefer an approach that does not require routine lab monitoring

Not the right fit if

  • You have had your vagus nerve cut (vagotomy) or your spleen removed (splenectomy)
  • You are looking for rapid relief of an acute flare — this builds over months, not days
  • Your RA is well controlled on your current treatment and you are happy with it
  • Your care team judges the procedure unsafe for you for another reason

How your care works

Getting the SetPoint System involves two specialists — a surgeon to place the device, and your rheumatologist to run everything else. What matters for you: you stay with Synergy through the whole process. We evaluate you, coordinate the surgery, and remain the ones managing your RA before and after.

  1. 1

    We confirm you are a candidate

    Dr. Fellows reviews your history, your prior treatments, and your goals to determine whether the SetPoint System is a reasonable option for you — and, just as important, whether it is not.

  2. 2

    We coordinate your referral

    If it makes sense, we connect you with SetPoint Medical and refer you to the implant surgeon. We help coordinate prior authorization and insurance so the path forward is clear.

  3. 3

    The device is implanted

    A partnering surgeon — currently Dr. Sanjay Ghosh at SENTA Clinic in San Diego — places the device during a short outpatient procedure. Most patients go home the same day.

  4. 4

    You return to us to turn it on

    Once the incision has healed, you come back to Synergy. We activate the device and adjust the stimulation gradually over two to three short weekly visits so it is comfortable for you.

  5. 5

    We monitor you over time

    From there, we see you about every three months to make sure the therapy is working and to fine-tune it — the same ongoing rheumatology care you would expect from us for any treatment.

Our surgical partner. The implant is currently placed by Dr. Sanjay Ghosh, a board-certified neurosurgeon at SENTA Clinic in San Diego. You can read about his background at SENTA Clinic.

The procedure and recovery

The device is placed during a short outpatient procedure — typically 60 to 90 minutes under general anesthesia — through a single incision of about an inch, positioned in a natural crease in the neck. Most patients go home the same day and are back to their normal activities the next.

The device is not switched on right away. A few days to about two weeks after surgery, once healing is underway, you return to Synergy and we activate it — adjusting the stimulation gradually over a couple of short weekly visits so that it is comfortable. As with any neck surgery there are real risks, which the surgeon reviews with you beforehand; for most patients the procedure and recovery are straightforward.

60–90 min

Outpatient procedure

~1 inch

Single incision, in a skin crease

Same day

Home to recover, back to activities next day

Reversible

Can be turned off or surgically removed

Living with the device

The day-to-day burden is deliberately small. Here is what it actually asks of you.

One automatic minute a day

Therapy runs on its own at a time we set — often early morning while you sleep. Some patients feel a brief tickle or cough during that minute; most notice nothing.

A few minutes of charging a week

The only regular task. Missing one charge is fine — you simply keep it from running down over time. The implant is designed to last up to 10 years.

MRI-conditional, travel-friendly

MRIs are allowed under standard safety conditions (just not within an hour of your daily therapy). X-rays and CT are unrestricted, and you pass through airport security normally with your implant ID card.

No routine lab monitoring

Because it does not suppress your immune system, there is none of the recurring bloodwork that biologics and JAK inhibitors require.

What the evidence shows

We would rather you hear the honest version from us than piece it together elsewhere. The SetPoint System was approved on the strength of a rigorous randomized trial of about 240 patients (called RESET-RA), in which some patients received active therapy and others a placebo device. Here is what it found.

~1 in 3

had a meaningful response at 3 months — versus about 1 in 4 with a placebo device

~1 in 2

had a meaningful response by one year, once on active therapy

44% vs 19%

response was highest in patients who had tried only one prior biologic

The honest read: this is a real but modest effect, and it works best earlier in the treatment journey — in people who have failed one advanced drug rather than several. Head-to-head, biologics still produce higher response rates for most patients. The reason to consider the SetPoint System is not that it is stronger, but that it comes with a very different trade-off: no immune suppression, no routine labs, and a one-time procedure instead of indefinite injections or infusions.

On safety: in the trial there were no deaths, and serious problems related to the device or procedure were uncommon (under 2%) and resolved. The most common side effect was a temporary change in the voice or hoarseness, in about 1 in 20 patients. Reassuringly, there was no increase in serious infections over the first year — though this is a young therapy, and long-term data is still being collected.

Want the primary source? The pivotal trial is registered as NCT04539964 and was published in Nature Medicine in 2025. We are glad to review the details with you.

Cost and insurance

Medicare now provides coverage for the SetPoint System, and commercial insurers are increasingly following. Coverage is handled case-by-case and generally requires prior authorization, which our office helps coordinate. Because coverage is still evolving and depends on your specific plan, there may be out-of-pocket costs associated with the implant procedure. We will be upfront with you about what to expect for your particular situation before you commit to anything — no surprises.

Questions patients ask

What is the SetPoint System?
The SetPoint System is a small, implanted device — about the size of a jelly bean — placed on the vagus nerve in the neck. Once a day, it delivers about one minute of gentle stimulation to that nerve, which prompts your body to naturally reduce the inflammation that drives rheumatoid arthritis. It is made by SetPoint Medical and received FDA approval in July 2025. It is the first implanted device of its kind approved to treat RA.
How can stimulating a nerve treat rheumatoid arthritis?
Your vagus nerve is part of a natural "off switch" for inflammation. When it is stimulated, it signals the spleen to dial down the production of inflammatory proteins — including TNF, one of the main drivers of RA. Biologic drugs block those same proteins from the outside; the SetPoint System instead uses your body's own nerve circuit to turn the inflammation down. It is a fundamentally different approach than any RA medication.
Will I feel the device working?
During the one minute a day that it is active, some patients notice a mild tickling sensation in the throat, a brief cough, or a slight change in their voice. Your rheumatologist can schedule the daily stimulation for a time that suits you — many patients have it set for early morning while they are still asleep and never notice it at all. The rest of the day, you feel nothing.
Will people be able to see the device, or feel it in my neck?
No. Once the incision has healed, the device sits deep enough that it is not visible and cannot be felt from the outside. The incision itself is small — about an inch — and is placed within a natural crease in the skin so that any scar is easy to hide and tends to fade over time.
Could it change my voice?
This is the most common side effect worth knowing about, because the device sits near the nerves that control the voice box. In the pivotal trial, about 1 in 20 patients had some hoarseness or a voice change. In most cases it was mild and improved over time; a small number needed voice therapy, and rarely it persisted. We will talk through this risk honestly with you before you decide.
Do I have to stop my other RA medications?
No. You are not required to stop methotrexate, a biologic, or a JAK inhibitor to receive the SetPoint System — it can be used alongside your current treatment. In the trial, many patients were able to avoid adding more medication over time, and some reduced what they were taking, but that is a conversation to have with your rheumatologist based on how you respond. It is not automatic and it is not required.
How long until it starts working?
This is not an overnight treatment. In the trial, improvement in joint tenderness and swelling was measured at about 3 months, and responses continued to build over the first year. If you are looking for rapid relief of a severe flare, the SetPoint System is not the tool for that moment — it is a steady, long-term approach.
How well does it actually work?
We want to be straight with you. In the pivotal trial, about 1 in 3 patients had a meaningful response at 3 months, compared with about 1 in 4 who received a placebo device — a real but modest difference. Once everyone was on active therapy, about half of patients had a meaningful response by one year. It worked notably better in people who had tried only one prior biologic (about 44%) than in those who had failed several. For most patients, biologics still produce higher response rates head-to-head. The SetPoint System is best thought of as a different option with a very different trade-off — not a stronger one.
Does it suppress my immune system the way biologics do?
No — and this is the main reason patients consider it. Biologics and JAK inhibitors work by broadly dampening the immune system, which is why they require routine lab monitoring and raise the risk of infection. The SetPoint System works through your nervous system instead, without that chronic immune suppression — so no routine labs and no ongoing infection monitoring. Its risks are mostly up front and surgical, rather than lifelong. An honest caveat: the safety data so far comes from about 240 patients over one year, which showed no increase in serious infections — but it is a young therapy, and we do not yet have decades of data.
Is the surgery a big deal?
It is an outpatient procedure that typically takes 60 to 90 minutes under general anesthesia, through a single incision of about an inch. Most patients go home the same day and return to their normal daily activities the next day. As with any surgery on the neck there are real risks — which the surgeon will review with you in detail — but for most patients the procedure and recovery are straightforward.
Can the device be removed if I change my mind or it does not help?
Yes. The device can be turned off, and it can be surgically removed. Keep in mind that removal is another procedure on the neck under anesthesia, carrying the same general risks as the original surgery — so it is not a decision to take lightly, but you are not permanently locked in.
Can I still get an MRI?
Yes, with conditions. The device is "MR Conditional," meaning MRI scans are allowed under specific safety guidelines defined in the device labeling. There is one practical rule: MRI should not be done within an hour before or after your scheduled daily therapy time. X-rays and CT scans have no restrictions. You will carry an implant ID card to show any provider before imaging.
What about airport security and metal detectors?
You can go through airport security normally. You will be given an implant ID card to carry and show to security staff if needed.
What do I have to do day to day?
Very little. The daily one-minute therapy happens automatically — you do not have to press anything. The device is rechargeable, and the only regular task is charging it for a few minutes about once a week. Missing a single charge is fine; the aim is simply not to let it run down repeatedly.
How long does the device last?
The implant is designed to deliver therapy for up to 10 years, after which it can be replaced by the surgeon. The external charger and dock are designed to last about 5 years and can be replaced through our office as needed.
Who is a candidate — and who is not?
The SetPoint System is approved for adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response, a loss of response, or intolerance to at least one biologic or targeted synthetic DMARD (a JAK inhibitor, for example). You do not need to have failed every medication first. It is not appropriate for people who have had the vagus nerve cut (vagotomy) or the spleen removed (splenectomy), or where your care team judges it unsafe. It tends to be most worth considering for patients who need to avoid immune-suppressing drugs — for example, those with a history of cancer or recurrent serious infections.
Who does the surgery, and what is my role at Synergy?
The implant is placed by a surgeon trained in the procedure. We currently partner with Dr. Sanjay Ghosh, a board-certified neurosurgeon at SENTA Clinic in San Diego. Your rheumatology care stays with us: Dr. Fellows confirms whether you are a candidate, coordinates the referral, and — once the device is placed and healed — activates it, programs it, and monitors your response over time. You stay with your rheumatologist through the entire process.
Does insurance cover it, and what will it cost me?
Medicare now provides coverage for the SetPoint System, and commercial insurers are increasingly following. Coverage is handled case-by-case and generally requires prior authorization, which our office helps coordinate. Because coverage is still evolving and depends on your specific plan, there may be out-of-pocket costs associated with the implant procedure. We will help you understand what to expect for your particular situation before you commit to anything.

The condition we treat with it

The SetPoint System is FDA-approved specifically for rheumatoid arthritis.

Rheumatoid Arthritis

Curious whether the SetPoint System is right for you?

It is not for everyone — but if you have RA and want to talk through whether this fits your situation, we are glad to walk you through it honestly.

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