Patients
How SetPoint Therapy Works
How does the SetPoint System Work?
SetPoint Therapy is a different approach to treating RA when compared to traditional drug-based treatment options.
SetPoint Therapy is a device-based therapy that works with your body by activating your body’s natural immune pathways known to have an anti-inflammatory effect.5 These immune pathways are thought to be dysfunctional in RA patients, which causes uncontrolled inflammation, the root cause of RA.3
The SetPoint System includes placement of a device on your vagus nerve with the intent to jumpstart, or activate, these pathways to reduce inflammation and restore your body’s inflammatory balance, or setpoint. In comparison, the typical approach of biologics and JAK inhibitors is to block/inhibit or target specific inflammatory markers or pathways.
Here is how Lynn, who participated in the RESET-RA study, describes how the therapy works: “This is a natural process. It’s just stimulating a part of your body. It’s telling it to say, hey, we need you to work.”
Hear Lynn’s experience with SetPoint Therapy.
Actual patient stories shared with their permission. Individual outcomes vary. Click here to see the full Important Safety Information.
How is SetPoint Therapy different from other rheumatoid arthritis (RA) treatments?
SetPoint Therapy is designed to treat rheumatoid arthritis (RA) by activating the body’s anti-inflammatory pathways to restore the balance of the immune system — reducing the inflammation that is the root cause of RA.3,4 This treatment approach uses a small (size of a multivitamin capsule) implantable vagus nerve stimulator that automatically delivers therapy for one minute each day, also known as neuroimmune modulation, instead of suppressing the immune system.
Does the SetPoint System suppress the immune system?
The SetPoint System is designed to regulate inflammation by activating the body’s natural anti-inflammatory reflex, rather than suppressing the immune system or specific immune pathways. This neuroimmune modulation approach restores the immune system’s balance and allows it to maintain its function to fight infections and disease. This targeted approach aims to help control inflammatory signals associated with rheumatoid arthritis (RA) while avoiding generalized immune suppression. 3,4
How often does the SetPoint System stimulate the vagus nerve?
The SetPoint System delivers stimulation once a day for one minute, and is delivered automatically.
When does the SetPoint System stimulation occur during the day?
The time of stimulation is set by your rheumatologist based on your preference. In the RESET-RA study, most patients received stimulation in the early hours of the morning, while they were typically asleep. The stimulation will occur automatically, and you do not need to do anything to turn it on each day. You will just need to charge the SetPoint System for a few minutes each week. This “set and forget” approach means you have more freedom to enjoy life on your terms.
What does stimulation from SetPoint Therapy feel like?
The feeling of stimulation varies from person-to-person. Patients who have received SetPoint Therapy describe stimulation as a mild tickling sensation, cough, or temporary change in voice during the one minute when the stimulation is delivered. Your rheumatologist programs the strength of SetPoint Therapy gradually over 2-3 weekly visits so it is comfortable for you.
Eligibility and treatment considerations
Who is eligible for SetPoint Therapy for rheumatoid arthritis (RA)?
Adults with moderately to severely active rheumatoid arthritis (RA) who did not respond well, lost response, or could not tolerate advanced RA drugs like biologics (e.g. Humira, Enbrel, Cimzia, Remicade, Rituxan, Actemra or Orencia) or JAK inhibitors (e.g. Xeljanz, Rinvoq or Olumiant) may be eligible for SetPoint Therapy. SetPoint Therapy, developed by SetPoint Medical, is prescribed by a rheumatologist, who, in partnership with the implanting surgeon, determines eligibility. Those who have had a vagotomy or splenectomy, or whose healthcare provider determines that it is not safe to use the SetPoint System, are not eligible for SetPoint Therapy.
Do I need to try every rheumatoid arthritis (RA) medication before considering SetPoint Therapy?
No, you do not need to try every rheumatoid arthritis (RA) medication before being considered for SetPoint Therapy. SetPoint Therapy was developed for adults who continue to struggle with moderately to severely active RA despite trying at least one antirheumatic drug (b/tsDMARDs). These could include biologics (e.g. Humira, Enbrel, Cimzia, Remicade, Rituxan, Actemra or Orencia) or JAK inhibitors (e.g. Xeljanz, Rinvoq or Olumiant). SetPoint Therapy may be an option for you if you had a poor response, lost response or were not able to tolerate the side effects of at least one of the above types of medications. Your rheumatologist determines whether SetPoint Therapy is appropriate for you based on medical history and symptoms.
Do I need to stop taking my rheumatoid arthritis (RA) medications before starting SetPoint Therapy?
No, you are not required to stop your rheumatoid arthritis (RA) medications to get SetPoint Therapy. SetPoint Therapy is a completely new treatment approach that activates your body’s own immune-balancing pathways, and can be used alongside existing treatments, such as DMARDs (e.g. methotrexate, hydroxychloroquine, sulfasalazine), biologics (e.g. Humira, Enbrel, Cimzia, Remicade, Rituxan, Actemra or Orencia) or JAK inhibitors (e.g. Xeljanz, Rinvoq or Olumiant). Together with your doctor, you can decide what’s right for you.
Is SetPoint Therapy the only vagus nerve stimulation treatment for rheumatoid arthritis (RA)?
SetPoint Medical has developed the first and only Food and Drug Administration (FDA)-approved vagus nerve stimulation device for the treatment of rheumatoid arthritis (RA). No other device, including external or non-invasive devices that claim to stimulate the vagus nerve in the ear or neck, is approved by the FDA to treat rheumatoid arthritis.
The SetPoint System is designed to stimulate the vagus nerve with specific parameters that target the specific nerve fibers to help regulate inflammation in the body. The SetPoint System delivers targeted stimulation intended to activate the body’s natural anti-inflammatory pathways and improve symptoms of RA.
Procedure, Implant and recovery
Do I need to go under anesthesia for the SetPoint System Implant procedure?
Yes. The SetPoint System is placed on the left vagus nerve, which is typically deep in the neck, so the implant procedure is performed under general anesthesia. SetPoint Medical designed the SetPoint System to ensure that the vagus nerve is consistently and precisely stimulated to activate the anti-inflammatory pathways.3 A surgeon with experience and training to implant this type of device places the SetPoint Implant in outpatient surgical setting and you can typically go home the same day and resume most activities of daily living the following day. Your surgeon will discuss the anesthesia and implant process with you prior to the procedure.
What should I expect before, during, and after the Implant placement procedure?
The first step of activating your SetPoint Therapy is to discuss this new therapeutic option with your rheumatologist or their team. To check if your rheumatologist offers SetPoint Therapy, please connect with the SetPoint Activator, or talk to your rheumatology provider.
Once you and your rheumatology care provider decide that SetPoint Therapy is the right option for managing your RA, they will refer you to a surgeon trained to place the SetPoint Implant. Next step would be to meet with the surgeon for a pre-operative visit to ensure that the procedure is right for you.
The actual placement procedure will be scheduled after your first surgeon appointment. The implant is typically placed during a 60-90 minute outpatient procedure, meaning that you typically return home the same day as the procedure and can resume activities of daily living the following day.8 The implant is placed via a small, 1-inch incision near a crease in the skin. You return to the surgeon a few days after the procedure for post-operative check. Click here to see examples of what the scar may look in patients who have had the SetPoint System.
A couple of weeks after the Implant is placed, you return to your rheumatologist who activates your therapy while ensuring that the stimulation is comfortable for you. Once activated, the therapy is automatically delivered daily. All you need to do is charge your device for a few minutes once a week. Your rheumatologist will continue to manage your RA. During these appointments, your therapy can be adjusted, if desired.
While results vary, this is how Lynn, a RESET-RA study participant, described the experience of her Implant placement procedure: “You’re implanted, your little scar heals, and you’re done. It was easily implanted. I had no downtime. I was literally in and out in the same day.”
Connect with a SetPoint Activator.
Actual patient stories shared with their permission. Individual outcomes vary. Click here to see the Important Safety Information.
Can you see or feel the SetPoint Medical Implant after surgery?
No. The SetPoint System implant is not visible and cannot be felt externally after it is placed. SetPoint Medical’s device is a small (about 1 inch, the size of a multivitamin) implant that is placed on the vagus nerve about 2-3 cm deep in the neck. Because of its location beneath the skin and surrounding tissue, patients cannot see or feel the Implant.
Does the SetPoint System implant procedure leave a scar?
The SetPoint System procedure typically involves a small surgical incision (about an inch) in the neck, typically placed within a natural crease in the skin. SetPoint Medical’s Implant is placed by a surgeon with experience and training with this type of device and they try to minimize visible scarring. Scar size and appearance will vary by individual. Some patients may have minimal to no visible scarring, while others may notice a small scar that typically fades over time as healing progresses.
How long does recovery take after the SetPoint System Implant procedure?
Recovery time after the SetPoint System Implant procedure varies by individual, but patients typically return to most normal activities of daily living the day after the procedure. As is the case with any medical procedure, you may experience pain, soreness or swelling as you heal. Your surgeon will provide specific recovery guidance based on their experience and your medical history.
Safety and Effectiveness
Is the SetPoint System safe and effective?
Yes, the SetPoint System has been clinically proven to be safe and effective. Specifically, the SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs such as TNF inhibitors or JAK inhibitors.
To support its FDA approval, the SetPoint System was evaluated in a clinical study of 242 patients which successfully met its primary endpoint for efficacy, and the device, its placement, and stimulation therapy were considered safe. The study now includes data through 12 months of follow-up that demonstrates sustained improvements in tender and swollen joints as well as disease activity; nearly half of patients treated with SetPoint Therapy for 12 months are in low disease activity or remission.*
The study also demonstrated that SetPoint System, its placement procedure as well as stimulation were safe and well tolerated. Serious adverse events related to the placement of the SetPoint System were observed in 1.7% (4 of the 242 people implanted) in the peri-operative 3 months, and no (0%) additional related serious events through 12 months of long-term follow-up.
SetPoint Therapy is intended to reduce inflammation by activating the body’s natural pathways while preserving the immune system’s primary protective functions.4,5 In the study, there were no serious infections, cancers, or major cardiac events associated with SetPoint Therapy.
This is how Dawn, who participated in the RESET-RA study, describes her personal experience with SetPoint Therapy: “I used to not be able to walk around the block, now I can walk for over an hour without any pain.”
Your doctor will review the risks associated with SetPoint Therapy before referring you for the therapy. A SetPoint Activator can help you connect with a rheumatologist in your area who is offering SetPoint Therapy.
Click here to connect with a SetPoint Activator.
Actual patient stories shared with their permission. Individual outcomes vary. Click here to see the full Important Safety Information.
*Analysis based on patients who were treated with SetPoint Therapy for 12 months without the addition of biologic, JAK inhibitors or high-dose steroids, or change in csDMARDs.
How long does it take for the SetPoint System to work?
The level of effectiveness and time to effectiveness varies from patient to patient. In the RESET-RA study, improvement in the number of tender and swollen joints and disease activity was seen by 3 months after starting stimulation. This response rate was higher in patients who had exposure to just one prior biologic.
While results vary, this is how RESET-RA participant, Patty, describes her experience: “After the device was activated, within a month, I started noticing differences. I wasn’t as tired […] I think the biggest thing was I started doing things again.”
Actual patient stories shared with their permission. Individual outcomes vary. Click here to see the full Important Safety Information.
What are the possible side effects of the SetPoint System?
The SetPoint System is placed on your vagus nerve during an outpatient procedure under general anesthesia. There are some risks associated with the device placement. Serious safety events related to the device, or its procedure, were observed in 1.7% (of the 242 study participants) in the RESET-RA study. All events were anticipated and consistent with learnings from more than 100,000 patients who have been treated with other vagus nerve stimulation devices for other indications over the past 20 years.
Other non-serious events, which typically resolve over time, include pain, redness and swelling at the implantation site, sore throat, cough or tingling as well as risks of vocal cord complications, that typically present as hoarseness – this was the most commonly observed side effect of the implant procedure occurring in about 5% (11 of 242 study participants).
Here is how Lynn, a RESET-RA study participant who experienced one of the more severe cases of hoarseness, described her experience with the side effect:
“It is normal to be hoarse right after surgery, but I couldn’t really speak. A whisper is all I could get out. So, I had to see a vocal cord specialist… I had a procedure done and the next day, I could talk like I had my voice back. Now, I can speak in a normal voice, and can be heard. But, as I’ve told everyone, if I had lost my voice completely, I would still have the implant because not being able to talk is fine when all my pain was taken away. Knowing what I know now, and having the effects with the vocal cord, 100% would still do SetPoint, 100%.”
The SetPoint System activates your natural immune pathways to reduce inflammation and symptoms of disease without compromising your immune system – allowing for RA symptom reduction while preserving the body’s ability to fight infections. 3,5,7 In the 12 months of follow-up in the RESET-RA study, there were no serious infections, cancers, or major cardiac issues associated with SetPoint Therapy.
Your doctors will discuss the risks of SetPoint Therapy with you.
Actual patient stories shared with their permission. Individual outcomes vary. Click here to see the Important Safety Information.
Travel, MRI, and other Medical procedures
Can I travel with the SetPoint System?
Yes, you can travel with the SetPoint System. If the duration of your travel is longer than a week, you need to carry your Charger and Docking Station with you to maintain your charging routine while away. The Charger and Docking Station should always be carried in the case provided by SetPoint Medical and should be packed in carry-on luggage when traveling by airplane.
Can I go through airport security or metal detectors with the SetPoint System?
Yes, you can go through airport security and metal detectors with the SetPoint System. After the completion of the implant placement procedure, you are provided with an Implant ID card that you can provide to the security personnel to inform them about your device. This card should be kept with you at all times, including when traveling.
Can I obtain medical imaging like X-ray, CT scans or MRI if I have the SetPoint System implanted?
Yes, you can obtain medical imaging after you have the SetPoint System implanted. For x-rays and CT scans, there are no restrictions, but you should present your implant ID card to your doctor and imaging technician to ensure they are aware of your implant.
For MRIs, the SetPoint System is MR Conditional, meaning that scans may be performed only under specific conditions. SetPoint Medical provides detailed MRI guidelines that healthcare providers must follow to ensure safe imaging. Specifically, you should not undergo MRI scans within 1 hour before or after the scheduled therapy time that is listed on your Therapy Parameters card.
What should I do if I need another surgery or medical procedure after receiving the SetPoint System?
If you need to undergo surgery or another medical procedure, you should inform your doctor that you have been implanted with the SetPoint System by presenting your Implant ID and Therapy Parameters cards. These cards have links that provide instructions for managing the device during certain medical procedures. Medical professionals can review the device guidelines to determine whether any precautions or temporary adjustments are required before you undergo another surgery or medical procedure.
Device longevity, maintenance and Support
What maintenance is required for the SetPoint System after implantation?
The SetPoint System is designed to simplify RA treatment. Once the SetPoint System is in place and activated, it delivers automatic therapy for a minute each day. All you need to do is charge your Implant for a few minutes each week with a Charger worn around your neck. Automatic stimulation means you have more freedom to enjoy your life on your terms.
In addition, your rheumatologist will monitor the device and adjust therapy as needed, during your routine appointments. SetPoint Therapy does not require monitoring blood work or labs that are typically needed with RA drugs.
What is included with the SetPoint System?
The SetPoint System includes the SetPoint Medical Implant and the following external components: Charger, Docking Station, Implant ID card and Therapy Parameters card.
How long does the SetPoint System device last?
The SetPoint System is designed to provide therapy for up to 10 years. SetPoint Medical’s Implant contains a rechargeable battery intended to support stimulation throughout its service life, after which the implant can be replaced by your surgeon.
The external components, including the Charger and Docking Station, are designed to last up to 5 years and can be replaced by your rheumatologist, as needed.
What happens if I forget to charge my SetPoint Implant?
The SetPoint Implant uses a rechargeable battery and is designed to continue delivering automatic therapy as long as the battery has sufficient charge. While missing a one-off charging session does not immediately stop SetPoint Therapy, prolonged or repeatedly forgetting to charge the implant could result in the Implant not delivering therapy. We recommend you establish a charging routine to charge the Implant once per week for a few minutes, to ensure uninterrupted therapy.
What should I do if I need help with my SetPoint System?
In the event that you need help with your SetPoint System, please contact your rheumatologist. SetPoint Therapy is prescribed and managed by your rheumatology care team, who can assess symptoms, check device function, and adjust therapy, if necessary.
Cost, Insurance and Access
How much does the SetPoint System cost for patients?
The exact cost of the SetPoint System procedure depends on a number of factors, including the surgery center’s charges, your insurance coverage, and individual plan benefits. Your out-of-pocket costs vary based on your deductibles, copays, coinsurance, and network status. SetPoint Therapy is a single implant procedure designed to provide up to 10 years of therapy. Once implanted, there are no additional costs to continue using the SetPoint System. SetPoint Medical is committed to working with your rheumatologist, surgeon and surgical center to help you access SetPoint Therapy.
Does insurance cover the SetPoint System?
Medicare, Medicaid, and many commercial or private insurance plans may cover SetPoint System on a case-by-case basis, and most commercial plans require prior authorization. Prior authorization means your provider submits clinical information to your insurance company for approval of the SetPoint System before you have the procedure. Your doctor will work with your insurance carrier to request this approval.
Can I travel to another location to be implanted with the SetPoint System?
Before considering travel, it is important to understand that receiving the SetPoint implant is not a one-time process. While each doctor’s approach will vary slightly, the process involves a rheumatologic and surgical evaluation before the procedure – this typically happens a few days before the implant procedure. Following implant placement, you will typically heal for a couple weeks before the SetPoint Therapy is activated. This activation process is then done weekly over 2-3 weeks. This ultimately means you will have multiple visits during the initial 6 weeks for therapy activation. Following that, rheumatologists typically see patients every 3 months to ensure the therapy is effective and to monitor the device. A SetPoint-trained rheumatologist will ultimately determine if you can travel to them to receive this therapy. We appreciate your patience while SetPoint Medical works on training rheumatologists and surgeons, and working with insurance providers across the United States on this new treatment option.
Providers
How does the SetPoint System work?
The SetPoint System is a neuroimmune modulatory device that treats RA and is designed to restore immunologic homeostasis.2,4,8 The SetPoint System consists of an integrated neurostimulator intended to activate innate anti-inflammatory processes to modulate multiple intracellular pathways,2,4,5 thereby reducing production of an array of proinflammatory cytokines5,6—providing a novel treatment option indicated for your biologic-experienced RA patients. The stimulation parameters of the SetPoint System are based on extensive preclinical biomarker analysis that indicated that a single 60-second daily stimulation reduces multiple cytokines, including TNF, IL-1β and IL-6, by 30-70%, providing symptom reduction without immunosuppressive risks.2,4,5,6
Is the SetPoint System safe and effective for treatment of RA?
The SetPoint System’s unique mechanism of action builds on over two decades of research and engineering, including the clinical experience from other devices that stimulate the vagus nerve, to provide you and your patients with the first neuroimmune modulation therapy for treatment of RA.
The SetPoint System’s safety and effectiveness were studied in the RESET-RA clinical study that enrolled 242 patients who were inadequate responders or intolerant to one or more biologics and/or JAK inhibitors. The study successfully met its primary endpoint of ACR20 at 3 months, with sustained improvements observed through 12 months of follow-up compared to baseline. With 12 months of therapy, nearly half of the patients were in DAS28-CRP low disease activity or remission.*
The SetPoint System, as well as the implant procedure, is considered safe.9 There was a low risk (1.7%, n = 4) of related serious adverse event rate in the peri-operative 3 months, with no (0%) related serious events occurring through 12 months. Additionally, through 12 months, there were no malignancies, major cardiac events, or serious infections associated with the SetPoint System, highlighting the safety of this novel therapeutic option.
To see detailed data, visit the Clinical Evidence page.
*Analysis includes only patients who were treated for 12 months without addition of biologic/JAK inhibitors/steroids/change in csDMARD.
Who is the ideal patient candidate for SetPoint Therapy?
The SetPoint System is indicated for adults with moderately to severely active RA who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic DMARDs.
Hence, the SetPoint Therapy could be considered for adult RA patients who have failed at least one biologic or JAK inhibitor and are seeking an alternative therapy; those who cannot tolerate these medications; those who are at high safety risks for JAK inhibition due to comorbid conditions; and those who had failed to get adequate disease control on biologics or JAK inhibitors.
In the RESET-RA study, improvement in the number of tender and swollen joints as well as disease activity was seen by 3 months after starting stimulation. This response rate was higher in patients who had exposure to just one prior biologic.
Based on its mechanism of action that manages the inflammatory process without immune suppression, SetPoint Therapy can be combined with biologics or JAK inhibitors if desired, preserving treatment options in the future.2,3,4,7
Do patients feel the implant or stimulation?
SetPoint Therapy is programmed to ensure comfort for the patients. Activation of the device includes a gradual increase of the stimulation level to ensure the therapy is not uncomfortable. Sensation of stimulation varies, but patients may feel a light tickling sensation, cough, or changes in voice during stimulation. The stimulation is delivered automatically for 60 seconds each day, and the rheumatologists can personalize the time of stimulation.
The SetPoint Implant typically cannot be felt or palpated externally.
What infrastructure does my clinic need to offer this to my RA patients?
We are committed to making it easy for you to offer SetPoint Therapy to your RA patients. Our Territory Manager will support your clinic’s onboarding process and can connect you with SetPoint-trained surgeons in your area.
Upon your clinic’s activation, SetPoint Medical will provide you and your team with the training and materials you’ll need to educate your RA patients on this therapy. SetPoint Medical will work directly with the surgical facility to help seek prior authorization for the procedure on your patient’s behalf. SetPoint Activators are available to help your patients navigate through the referral, prior authorization, and implant placement processes.
A couple of weeks after the implant procedure, the patient will return to your office to have therapy activated using an iPad-based app, which SetPoint Medical will provide. After activation, the therapy is delivered automatically for 60 seconds each day.
If you have additional questions, please contact your SetPoint Territory Manager
What is the implant procedure like?
The SetPoint System is typically placed during a 60-to-90 minute outpatient surgical procedure under general anesthesia.7 Patients typically go home the same day as the procedure and resume activities of daily living the following day.
The SetPoint Implant is placed by a surgeon who is experienced with procedures involving the vagus nerve, typically a functional neurosurgeon or an ENT surgeon. Your Territory Manager can help to identify trained surgeons near you. Additionally, SetPoint Medical will assist with the prior authorization process for the SetPoint procedure and will keep you and your patients informed to ensure a best-in-class experience for your patients and your staff.
If you have additional questions, please contact your Territory Manager
How does the vagus nerve control inflammation?
The vagus nerve plays a central role in modulating inflammation.8,9 Excessive inflammation plays a role in causing and advancing many autoimmune diseases, such as rheumatoid arthritis (RA). The sensory neurons within the vagus nerve detect and respond to inflammatory mediators by sending signals to the brainstem.8 Signals reflexively travel back into the body through motor fibers within the vagus nerve to enact the homeostatic control of both immune responses and restorative pathways through these linked innate neuroimmune reflexes.4,8
This pathway is thought to be dysfunctional in patients with RA causing increased inflammation that contributes to pain and swelling of the joints, putting patients at risk of joint deformities and disability if not well managed.3 Electrically stimulating the vagus nerve with precise parameters activates fibers of the vagus nerve that activate cholinergic anti-inflammatory processes that are intended to restore immunologic balance and reduce the release of inflammatory cytokines.2,4,10
How do you place the SetPoint Implant?
The SetPoint System includes a small, leadless, integrated neurostimulator that is placed directly on the left vagus nerve through a single incision during an outpatient procedure under general anesthesia. The implant is placed on the nerve within a flexible silicone Pod.
To implant the device, the vagus nerve is accessed, and then the Pod is placed under and around the nerve. The Implant is then placed in the Pod, which is then sutured closed holding the neurostimulator against the vagus nerve.
An integrated, leadless implant with rechargeable battery means there is no need to coil electrodes around the nerve, tunnel the lead, or to create a chest pocket for a separate battery.
Please see complete placement instructions in the Surgical Manual.
What patients are indicated for the SetPoint System?
The SetPoint System is indicated for adult patients with moderately to severely active RA who have had an inadequate response, loss of response, or intolerance to one or more biologic (e.g. TNF inhibitors) or targeted synthetic RA drugs (e.g. JAK inhibitors).
Can you tell me more about reimbursement for the SetPoint System?
Billing codes for the single incision implant, replacement, and removal procedures for the SetPoint System have been established. We have worked with the American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), and American College of Rheumatology (ACR) to establish these CPT codes.
SetPoint Therapy is covered by insurances on a case-by-case basis, subject to prior authorization.
SetPoint Medical’s commitment to making SetPoint therapy accessible to patients means that we will work directly with the referring rheumatologist and the surgical facility to help seek prior authorization for the SetPoint Implant procedure on your patient’s behalf. You, your team, and your patients will be kept informed throughout the process to ensure a best-in-class experience.
How long does it take to see improvements in RA symptoms?
The SetPoint System is intended to improve RA by activating the innate anti-inflammatory and immune restorative pathways that reduce multiple cytokines, including TNF, IL-1β, and IL-6, by 30-70% to reduce inflammation without immunosuppression side effects.1,4,5,6
In the RESET-RA study, improvement in the number of tender and swollen joints and disease activity was seen by 3 months after starting stimulation. This response rate was higher in patients who had exposure to just one prior biologic.
Uniquely, due to its mechanism and safety profile, SetPoint Therapy can be combined with biologics or JAK inhibitors if desired, providing more treatment approaches to adequately control your patient’s disease.
To see detailed data, visit the Clinical Evidence page.
*Analysis includes only patients who were treated for 12 months without the addition of biologic/JAK inhibitors/high-dose steroids/change in csDMARD.
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3. Koopman FA, Tang MW, Vermeij J, et al. Autonomic Dysfunction Precedes Development of Rheumatoid Arthritis: A Prospective Cohort Study. EBioMedicine. 2016;6:231-237
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5 Chavan SS, Pavlov VA, Tracey KJ. Mechanisms and Therapeutic Relevance of Neuro-immune Communication. Immunity. 2017;46(6):927-942.
6. Koopman FA, Chavan, SS, Miljko A, Grazio Simeon, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis.
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8. Tracey KJ. The inflammatory reflex. Nature. 2002;420(6917):853-859.
9. Andersson U, Tracey KJ. Neural reflexes in inflammation and immunity. J Exp Med. 2012;209(6):1057-1068.
10 Levine YA, Faltys M, Chernoff D. Harnessing the Inflammatory Reflex for the Treatment of Inflammation-Mediated Diseases. Cold Spring Harb Perspect Med. 2020;10(1):a034330.
