FDA-approved vagus nerve stimulator for rheumatoid arthritis, approved July 2025. Values come from the FDA summary of safety and effectiveness; trial efficacy numbers were not extracted.
Catalog specification sheet - Peripheral nerve
SetPoint vagus nerve stimulation for rheumatoid arthritis
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
SetPoint vagus nerve stimulation for rheumatoid arthritis
The SetPoint System is an FDA-approved vagus nerve stimulator for rheumatoid arthritis, approved by PMA P240039 on July 30, 2025. This sheet comes from the FDA summary of safety and effectiveness. Efficacy results and some electrical specifications were not extracted and stay Unreported.
Identity
Field
Value and source scope
Device
SetPoint System: integrated Implant in a silicone Pod, Charger, Docking Station and Patient ID Card [1]
Manufacturer
SetPoint Medical, Valencia, California [1]
Interface class
Integrated neurostimulator seated on the left cervical vagus nerve in a silicone Pod [1]
Origin
Commercial FDA-approved device, PMA P240039; FDA breakthrough designation granted [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Human (SPM-008, SPM-011, SPM-020) and canine safety studies [1]
Regulatory status
PMA P240039 approved July 30, 2025, with no panel recommendation. The SSED states the system had not been marketed in the United States or any foreign country at that time [1]
Function
Delivers vagus nerve stimulation once per day for 1 minute for rheumatoid arthritis [1]
Target tissue
Left vagus nerve at the neck [1]
Geometry and architecture
Field
Value and source scope
Interface type
Implant about 2.5 cm (1 in) long, about 3 g (0.1 oz); the nerve sits in the Pod’s groove and the Pod is closed with a suture through suture holes [1]
Array layout
Unreported
Electrode count
Unreported
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Surgical placement next to the vagus nerve on the left side of the neck [1]
Anchoring and fixation
Flexible silicone Pod holds the Implant in place and is sutured closed [1]
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Once per day for 1 minute at 10 Hz; titrated to the maximum tolerated strength with a maximum amplitude of 2500 uA and pulse width of 250 us (6.05 uC/cm2 charge density) [1]
Charge injection limit
Maximum allowed output equals 6.05 uC/cm2 charge density per the SSED; this is a programming limit, not a material limit [1]
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Integrated implant; the Docking Station logs doses delivered or missed and battery charge levels [1]
Data path
Docking Station reports use of the Implant and Charger [1]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable by a neck-worn Charger used about once a week for about 10 minutes; not for patients who cannot safely use it, including those with a pacemaker or defibrillator [1]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Unreported
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Labeled effects include hoarseness or voice change, throat pain or pharyngitis, dizziness, vagus nerve or surrounding tissue damage, Horner’s syndrome from sympathetic chain compression, infection and implant migration [1]
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
SPM-008: 14 patients with highly drug-refractory RA (IDE G170231, 4 US sites, randomized, blinded, sham controlled). SPM-011: long-term extension. SPM-020 (RESET-RA): randomized, sham-controlled, double-blind, 41 US sites; enrollment not extracted here [1]
Preclinical cohort
Twelve canines implanted on the left vagus nerve (cohorts of 6 to day 42 and day 180); study 111-20 in 16 canines tested output escalation and explant safety [1]
Follow-up duration
Unreported
Indications
Adults with moderately to severely active rheumatoid arthritis who had inadequate response, loss of response or intolerance to one or more b/tsDMARDs [1]
Trials and registries
IDE G170231 (SPM-008), SPM-011, SPM-020 (RESET-RA); registry IDs not extracted here [1]
Primary outcomes
Unreported
Key limitations
Efficacy results of RESET-RA were not extracted from the SSED text read here and stay Unreported. Contraindicated in patients who cannot safely have surgery or use the Charger [1]
Engineering tradeoffs
Field
Value and source scope
Strengths
Fully implanted integrated device with once-daily 1-minute dosing [1]
Limitations
Weekly charging; neck-worn charger excludes some patients [1]
Scaling constraints
Unreported
Version boundary
There is one approved system configuration. The SSED reports that the system had not been marketed anywhere when approved.