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FDA approves first implant to treat rheumatoid arthritis
New Atlas ^ | August 26, 2025 | Bronwyn Thompson

Posted on 08/26/2025 9:41:03 AM PDT by Red Badger

The first-ever neuroimmune modulation implant has been approved for people with moderate to severe rheumatoid arthritis (RA) who haven't found relief with traditional medications. It's a potentially life-changing technology that can zap pain by delivering one-minute electrical pulses to the vagus nerve – a key neural pathway that regulates inflammation.

The US Food and Drug Administration (FDA) has greenlit the device developed by California's SetPoint Medical, based on positive outcomes from the RESET‑RA clinical trial – a 242-patient, randomized, double-blind, sham-controlled study. It showed measurable improvements in disease activity by three months, with sustained benefits at 12 months. Impressively, 75% of participants were using just the implant and no other therapeutics after just 12 months.

We covered earlier trial stages of the device, which is about the size of a vitamin or coffee bean, back in 2021. However, the SetPoint System has been in development for two decades.

The tiny device takes the form of a miniature neurostimulator enclosed in a ceramic and titanium case. It is implanted in the left side of the neck via a minimally invasive outpatient procedure, under anesthetic.

It then delivers electrical stimulation to the vagus nerve once a day for up to a decade, activating the innate anti-inflammatory and immune-restorative pathways to block the dysfunctional signaling that causes the pain. Patients use a digital platform that tailors pulse dosage to their needs, and it can be recharged wirelessly once a week via a collar-like neckband.

(Excerpt) Read more at newatlas.com ...


TOPICS: Business/Economy; Health/Medicine; Military/Veterans; Society
KEYWORDS: arthritis; neckband; neurostimulator; rheumatoid

1 posted on 08/26/2025 9:41:03 AM PDT by Red Badger
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To: ConservativeMind

Ping!.................


2 posted on 08/26/2025 9:41:20 AM PDT by Red Badger (Homeless veterans camp in the streets while illegals are put up in 5 Star hotels....................)
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To: Red Badger

bkmk


3 posted on 08/26/2025 9:44:30 AM PDT by sauropod (Trump did the stupid party a favor. He gave them balls the size of Jupiter. )
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To: Red Badger

bump to the top


4 posted on 08/26/2025 9:44:33 AM PDT by GOPJ (DEMOCRAT HELLHOLE CITIES HAVE HAD 60 YEARS TO DEAL WITH THEIR CRIMINAL PROBLEMS.)
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To: Red Badger

Upon reading this, I was somewhat concerned about unintended side effects. Like , is there any affect on nerves other than the vagus nerve? My husband said that wasn’t going to be a problem. After all, what happens in vagus, stays in vagus.


5 posted on 08/26/2025 9:48:23 AM PDT by married21 (As for me and my house, we will serve the Lord.)
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To: married21

6 posted on 08/26/2025 9:54:00 AM PDT by Red Badger (Homeless veterans camp in the streets while illegals are put up in 5 Star hotels....................)
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To: Red Badger

A lot of people with rheumatoid arthritis really have hormone issues.


7 posted on 08/26/2025 10:07:52 AM PDT by goodnesswins (Democracy to Demo rats is stealing other peoples money for their use, no matter how idiotic)
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To: Red Badger

Ping


8 posted on 08/26/2025 10:14:22 AM PDT by butterdezillion
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To: married21

Lol. Good one! My daughter is researching vagus nerve stimulation
I should ask her about this. I wonder if it would affect arthritis that’s not rheumatoid.


9 posted on 08/26/2025 10:17:00 AM PDT by butterdezillion
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To: butterdezillion

Probably would not wok on osteoarthritis as the causes are different. It’s not inflammatory, but degenerative.


10 posted on 08/26/2025 10:26:57 AM PDT by HollyB
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bookmark


11 posted on 08/26/2025 10:29:25 AM PDT by freds6girlies (many that are first shall be last; and the last shall be first. Mt. 19:30. R.I.P. G & J)
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To: goodnesswins
“…A lot of people with rheumatoid arthritis really have hormone issues.”

.

Tell me more, please?

12 posted on 08/26/2025 11:03:49 AM PDT by GaltAdonis
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To: Red Badger

Can zap pain by delivering one-minute electrical pulses to the vagus nerve.

With my luck the laser will be the one they take down planes with.


13 posted on 08/26/2025 11:36:06 AM PDT by Vaduz
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To: Red Badger

<>sham-controlled study<>

Sham-controlled?

Educate me.


14 posted on 08/26/2025 11:57:45 AM PDT by Jacquerie
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To: Jacquerie

https://eurointervention.pcronline.com/article/evaluating-the-importance-of-sham-controlled-trials-in-the-investigation-of-medical-devices-in-interventional-cardiology


15 posted on 08/26/2025 11:59:22 AM PDT by Red Badger (Homeless veterans camp in the streets while illegals are put up in 5 Star hotels....................)
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To: Jacquerie

GOOGLE AI:

In medical research, sham-controlled refers to a type of clinical trial designed to test procedures or devices by comparing the active treatment against a “sham” or fake procedure. This is similar to a placebo-controlled trial, but is used when a physical intervention, rather than a pill, is being tested.
The goal of a sham-controlled trial is to isolate the specific effects of the treatment by creating a control group that experiences the same sensory and psychological aspects of the procedure, but without the key therapeutic component.

How sham-controlled trials work

Trial groups: Participants are typically divided into two groups through a randomization process:
Treatment group: Receives the genuine medical device or procedure being studied.

Sham-control group: Undergoes a fake version of the procedure that looks and feels real, but has no actual therapeutic effect.

Blinding: To prevent bias, these studies are often “blinded,” meaning participants do not know whether they are receiving the real or sham procedure. Sometimes, the practitioners are also blinded, known as a double-blind study.

Controlling for the placebo effect: A sham-controlled design helps researchers distinguish between the true effects of the treatment and the placebo effect, where a patient’s belief in the treatment leads to a perceived improvement. By comparing outcomes between the two groups, researchers can determine if the treatment itself is actually effective.

Examples of sham-controlled trials

Sham acupuncture: Some participants receive real acupuncture, while the sham-control group has needles placed in non-therapeutic areas or uses blunted needles that do not penetrate the skin.

Sham surgery: In a trial for knee surgery to treat osteoarthritis, some patients received the standard surgery, while the control group received an incision but no repair was performed. Both groups received the same pre- and post-operative care.

Sham devices: Trials for medical devices, such as those used for pain management, may compare an active device against a sham device that appears identical but is not turned on or functioning.
Ethical considerations

Sham-controlled trials, particularly those involving invasive procedures, are often controversial due to ethical concerns about exposing the control group to the risks of a procedure without any potential benefit. For this reason, these trials require robust informed consent and are often reserved for conditions where there is no existing, proven treatment.


16 posted on 08/26/2025 12:01:31 PM PDT by Red Badger (Homeless veterans camp in the streets while illegals are put up in 5 Star hotels....................)
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To: Red Badger
Vagus nerve: key neural pathway that regulates inflammation

It also happens to be the bulk of your entire parasympathetic nervous system. What could possibly go wrong?

17 posted on 08/26/2025 12:17:58 PM PDT by FoxInSocks ("Hope is not a course of action." — M. O'Neal, USMC)
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To: FoxInSocks

18 posted on 08/26/2025 12:19:18 PM PDT by Red Badger (Homeless veterans camp in the streets while illegals are put up in 5 Star hotels....................)
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