ID: 335853 Initial Clinical Safety and Feasibility from RESET-RA Study: Novel Neuroimmune Modulation Device for Rheumatoid Arthritis

Document Type

Conference Proceeding

Publication Date

10-1-2024

Publication Title

Neuromodulation: Technology at the Neural Interface

Abstract

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). The RESET-RA study (NCT04539964) is a randomized, double-blind, sham-controlled, multi-center, two-stage pivotal study that evaluates the safety and efficacy of a novel neuroimmune modulation device in patients with moderate-to-severe RA who are incomplete responders or are intolerant to one or more biological or targeted synthetic drugs. We report the safety data of the surgical implantation and use of this device in the first 60 subjects enrolled in the study. 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 left vagus 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 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) related to the implant procedure, device, or stimulation 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 improved with speech therapy and resolved with minor sequelae and no impairment. Conclusion: Initial results through 12 weeks of follow-up demonstrated that implantation and programming of the novel neuroimmune modulation device were safe, and the surgical procedure and device were well tolerated in patients with moderate-to-severe RA. Disclosures: P. David Adelson, MD: None, Warren Boling, MD: None, James Botros, MD: None, David Chernoff, Md: SetPoint Medical: Employee, Howard Eisenberg, MD: Insightec: Contracted Research, NFL: Contracted Research, Idorsia Pharma: Contracted Research, Andrew Ko, MD: None, Peter Konrad, MD, PhD: SetPoint Medical: Contracted Research, Medtronic: Consulting Fee, Bradley Lega, MD: Bia Therapeutics: Ownership Interest: Own Stock, Stock Options, Future Stock Options, Ashesh Mehta, MD: None, Daniel Peterson, MD: Alafair Biosciences: Ownership Interest: Own Stock, Stock Options, Future Stock Options, Mark Richardson, MD, PhD: SetPoint Medical: Consulting Fee, Perry Santos, MD: None, Jason Schwalb, MD: MeiraGTx: Contracted Research, Nevro: Contracted Research, Neuros: Contracted Research, SetPoint Medical: Contracted Research, Medtronic: Contracted Research, Heather Spader, MD: None, Mark Van Poppel, MD: None, Frank Vrionis, source=Web Response, Ashley Waterstone: SetPoint Medical: Employee

Volume

27

Issue

7

First Page

S189

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