Living With SetPoint Therapy
When considering a new treatment for rheumatoid arthritis, the clinical data matters, but so do the practical questions. What does the treatment actually involve? What will the therapy feel like once it’s activated? How much maintenance does it require? And what happens over the long term?
Here’s what daily life with SetPoint Therapy looks like, with real SetPoint patients sharing their experiences on everything from the procedure itself to the day-to-day reality of living with the device. We are grateful to them for giving us their permission to share their stories.
Like with any medical treatment outcomes vary from person to person. If you think SetPoint Therapy might be right for you, the first step is talking with your rheumatologist. They can help you understand whether you might be a candidate based on your treatment history and current disease activity.
Device Placement Procedure: What to Expect
The SetPoint System is placed on the left vagus nerve during an outpatient procedure that typically takes 60 to 90 minutes. A surgeon places the small device – about the size of a multivitamin – directly on the vagus nerve through a small (~1-2 inch) incision on or near a natural crease in the skin. General anesthesia is administered during the procedure, and most patients can go home the same day and can typically resume normal daily activities the following day.
As Lynn, who participated in the study that led to the SetPoint System’s FDA approval, described it: “To me, I wish there was another word for the procedure other than surgery, because it was so minimally invasive.”
For a closer look at what the procedure, recovery, and activation process are like from a patient’s perspective, see The SetPoint Implant Procedure: What to Expect.
The treating physician will advise patients on any specific precautions during the healing period, such as temporary limits on lifting or strenuous activity.
To me, I wish there was another word for the procedure other than surgery, because it was so minimally invasive.
- Lynn M., North Carolina
Implant Activation and the First Few Weeks with SetPoint Therapy
Your rheumatologist activates the device at a follow-up appointment, typically a couple weeks after the implant procedure. The time of stimulation is set by your rheumatologist based on your preference. Your rheumatologist programs the strength of SetPoint Therapy gradually over 2-3 weekly visits so it is comfortable for you.
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.
The response to therapy in the early days can vary from patient to patient. Some may start seeing improvements in their symptoms, while others, particularly those with long-standing disease and multiple prior medications may not see significant changes for the first few months. Because SetPoint Therapy works by restoring the body’s natural anti-inflammatory pathway, it could take time to restore immune balance.
Daily Sensations: What Stimulation Feels Like
Once activated, the SetPoint System delivers one stimulation per day, lasting one minute. The device runs automatically at a programmed time determined between you and your rheumatologist.
It’s just a little vibration in the neck, and then it goes away, and that’s it. There’s nothing that hurts. There’s nothing painful about it at all.
- Bridgette S., Arizona
The feeling of stimulation varies from person-to-person. Patients receiving SetPoint Therapy describe stimulation as a mild tickling sensation, cough, or temporary change in voice during the one minute when the stimulation is delivered. If stimulation ever becomes uncomfortable, your rheumatologist can adjust the programming to match your comfort level.
Here is how Bridgette, who has been on SetPoint Therapy for over 3 years, described the stimulation: “It’s just a little vibration in the neck, and then it goes away, and that’s it. There’s nothing that hurts. There’s nothing painful about it at all.”
Charging: Once a Week for Just a Few Minutes
The SetPoint System is powered by a small rechargeable battery inside the Implant. You charge it externally using a wireless charger that rests around your neck. We recommend you establish a routine to charge the Implant once per week for a few minutes, to ensure uninterrupted therapy. The charger signals when it is finished.
Activity with SetPoint Therapy: Getting Back to Daily Life
The SetPoint System is designed to fit seamlessly into your life. The implant can’t be felt from outside the body, therapy is delivered automatically, and there’s nothing you need to do on a day-to-day basis apart from charging for a few minutes once a week.
The treatment travels with you. Whether you’re at home, at work, or on a trip, the therapy runs on its own. When flying, you pack the charger in your carry-on and keep your Patient ID Card handy for security. Beyond that, your life is yours.
Bridgette, who cares for horses, emus, and other rescue animals at her home in Arizona, put it this way: “My implant has simplified my life by being able to plan things and keep those plans, to be able to set a schedule and keep that schedule, where before it was one day at a time.”
Speak with a Patient Activator
Cybersecurity: Can Someone Hack into My Implant?
The SetPoint System is designed with multiple layers of security to prevent any unauthorized person from accessing the device.
The Implant can only communicate with an app on the iPad under a very specific set of conditions: the patient must be wearing the charger AND needs to be near someone with an iPad with the SetPoint programming app AND an authenticated user must be actively logged into the app. The Implant cannot be accessed remotely or when the Charger is not worn by the patient. It is not broadcasting a signal or accepting input. Other external devices cannot scan or connect to it.
The SetPoint System undergoes rigorous cybersecurity testing as part of the FDA approval process, meaning the security of the device has been independently evaluated, not just internally assessed. We are constantly updating our systems to ensure the SetPoint System complies with the most up to date cybersecurity controls in accordance with FDA’s cybersecurity guidance.
For patients who have spent years managing a chronic illness, the last thing you want to worry about is the safety of the device helping to treat it. The SetPoint System is built so you don’t have to.
Long-Term Use: What to Expect Over Time
Rheumatoid arthritis doesn’t go away, and that means any treatment worth considering must do more than deliver short-term relief. It needs to work over the long haul, without adding new burdens or risks along the way.
SetPoint Therapy was built with that in mind. The Implant’s rechargeable battery is designed to power your therapy for up to 10 years. SetPoint Medical has patients from its earliest pilot study who have now been living with SetPoint Therapy for eight years and continue to do well. And vagus nerve stimulation devices more broadly have been implanted in patients for decades across a range of conditions, so the underlying technology has a long track record.
In clinical studies, response rates increased as patients continued on the therapy, with more than half of participants who completed the study showing meaningful improvement by one year. Your rheumatologist will continue to manage your RA with you, and therapy can be adjusted during those appointments if needed.
Ken, who has been living with SetPoint Therapy for over 3 years since participating in the clinical trial that led to its FDA approval, described the peace of mind that comes with treatment longevity: “The treatment is here (points to his neck), and it will be here for 10 years before I have to really start thinking about it again.”
Patients with the SetPoint Implant should also be aware of ongoing considerations. X-rays, CT scans, ultrasounds, and PET scans can all be performed without restrictions, but patients should present their Implant ID card to their doctor and imaging technician so they are aware of the device. The SetPoint Implant is MR Conditional, meaning MRIs can be performed only under specific conditions. Patients need to wait at least two weeks after implantation before having an MRI, and any future MRI must not be scheduled within one hour before or after their daily therapy time.
Beyond imaging, scuba diving and the use of hyperbaric chambers are not recommended, since high pressure could damage the device. Certain medical procedures around the neck that involve electrical current, heat, or radiation, such as electrosurgery, diathermy, TENS, electroconvulsive therapy, lithotripsy, and radiation therapy, may also need to be carefully evaluated. SetPoint Medical provides an Implant ID card and Therapy Parameters card to share with any healthcare professional before any treatments, imaging, or other procedures, so they can take the device into account.
Your rheumatologist and surgical team can help you weigh the potential benefits and risks based on your individual health history and treatment goals. For a closer look at the safety data and side effects reported in the clinical trial, see our article on Neuroimmune Modulation for Rheumatoid Arthritis: Safety, Side Effects, & What the Research Shows.
A Treatment That Fits Into Your Life
The SetPoint System was designed to be low maintenance. For people who have spent years managing multiple complex medication schedules, navigating insurance re-authorizations, spending time in infusion appointments, and dealing with side effects, that simplicity can make a real difference.
The treatment is here, and it will be here for 10 years before I have to really start thinking about it again.
- Ken H., Rhode Island
Over time, the daily experience with the device tends to settle into a simple, predictable routine: one minute of stimulation you may or may not notice, a brief weekly charge, and regular check-ins with your rheumatologist.
As Patty, another clinical study participant, put it: “Before SetPoint Therapy, I was an RA patient, and now I’m just Patty again.”
Every patient’s treatment plan is different, and some may still take other medications alongside the SetPoint System depending on their individual needs. Your rheumatologist will work with you to determine the right approach for your situation.
Is SetPoint Therapy Right for You?
SetPoint Therapy is for adults with moderately to severely active RA who have tried one or more biologics (e.g. Humira, Enbrel, Cimzia, Remicade, Rituxan, Actemra, or Orencia) or JAK inhibitors (e.g. Xeljanz, Rinvoq, or Olumiant) and didn’t get adequate results, lost their response over time, or couldn’t tolerate the side effects. If your current treatment isn’t giving you relief, or you haven’t been able to tolerate it, SetPoint Therapy may be worth discussing with your rheumatologist.
You can complete a short form to find out if it might be a good fit for you. If you’re a potential candidate, you’ll be connected with a Patient Activator from our team who can help answer your questions and walk you through next steps.
You may also want to bring up SetPoint Therapy at your next visit directly with your rheumatologist. They can help you evaluate whether the SetPoint System might be appropriate based on your treatment history and current disease activity.