Is the SetPoint System safe for people with RA? That's a great question, especially since it's a brand-new option.
The SetPoint System is an FDA-approved implantable device designed for adults with moderate-to-severe RA who haven't responded well to biologics or JAK inhibitors. It works by sending gentle electrical pulses Show Full Answer
Is the SetPoint System safe for people with RA? That's a great question, especially since it's a brand-new option.
The SetPoint System is an FDA-approved implantable device designed for adults with moderate-to-severe RA who haven't responded well to biologics or JAK inhibitors. It works by sending gentle electrical pulses to the vagus nerve in the neck, which helps calm the overactive immune response that causes joint pain and swelling in RA. Based on clinical trial data, it appears to be reasonably safe, but like any surgical procedure, it does carry some risks. Here's what the trials showed:
- The most common side effect was hoarseness, affecting about 5% of participants
- Serious side effects occurred in just under 2% of participants
- Most serious side effects happened within the first three months
- Risks were typical of nerve surgery, such as pain or infection at the implant site
On the positive side, nearly half of participants achieved low disease activity or remission after 12 months, and 75% were able to stay off biologics or advanced medications for a full year.
It's worth having a detailed conversation with a rheumatologist to weigh the risks and benefits based on individual health history, especially since the device is still rolling out across the U.S.
August 15
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