136 Initial Clinical Safety and Feasibility From the RESET RA Study of a Novel Implantable Neuroimmune Modulation Device for the Treatment of Rheumatoid Arthritis

INTRODUCTION: Electrical stimulation of the vagus nerve activates the inflammatory reflex to inhibit cytokines and decrease clinical signs and symptoms of chronic inflammatory disease such as rheumatoid arthritis (RA) (Genovese et al. Lancet Rheum 2020). METHODS: The device system consists of two implanted components: a miniature integrated pulse generator and a silicon sleeve positioning device that holds the generator in apposition to the nerve. There are two external components: a wireless charger and an iPad application for programming the pulse generator. Subjects were randomly assigned (1:1) after device implantation on the left vagus nerve to receive active or sham stimulation. The risks of the surgical procedure, device, and stimulation were blindly assessed after 12 weeks of stimulation therapy in the first 60 subjects enrolled in the study. RESULTS: All implant procedures were completed without intraoperative complications, infections, or surgical revisions. No unanticipated adverse events (AEs) were reported during the perioperative period and at the end of 12 weeks of follow-up. No serious AEs related to the device, stimulation, or explant procedures were reported. Vocal cord paresis and prolonged hoarseness were reported in two subjects. The former resolved following vocal cord augmentation with injectable filler; the latter is ongoing and improving with speech therapy. CONCLUSIONS: Initial results demonstrated that implantation and programming of the novel neuroimmune modulation device were safe, and the surgical procedure and device were well tolerated.