Authors: Benjamin L. Reed, MD, Nova Szoka, MD
Innovative Health Solutions received FDA approval to market IB-Stim on June 7th, 2019.
IB-Stim (formerly Neuro-Stim) is a percutaneous nerve stimulator intended for use as an adjunct in the treatment of abdominal pain in adolescent patients with irritable bowel syndrome (IBS). The device consists of a small, battery-powered, electrical generator that is secured behind the ear with Steri-Strips. The generator is connected by wires to four needle electrodes that are implanted near neurovascular bundles around the ear with the intent of stimulating the auricular branch of the vagal nerve, as well as other nerves that innervate the ear. Periauricular nerve stimulation is thought to disrupt dysfunctional autonomic feedback loops that cause pain in patients with IBS.
The efficacy of the device was evaluated in a randomized, controlled trial funded by the Medical College of Wisconsin and American Neurogastroenterology and Motility Society. In the study, adolescent patients with IBS were randomized to nerve stimulation using IB-Stim or sham for 3 weeks. Patients in the treatment group were found to have decreased median pain scores both at the conclusion of the study and at 9-week follow-up .
IB-Stim was approved via the de novo premarket review pathway, and is not substantially equivalent to any predicate devices. Innovative Health Solutions has obtained FDA approval in the past for similar devices for use in treatment of opioid withdrawal and with acupuncture.
The device is approved by the FDA for the treatment of functional abdominal pain associated with IBS in patients aged 11-18 when combined with other therapies for IBS. The device may be used up to 120 hours per week for up to 3 weeks. Contraindications include hemophilia, psoriasis vulgaris, and the presence of a cardiac pacemaker.
- Kovacic K, Hainsworth K, Sood M, et al. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. The Lancet Gastroenterology & Hepatology. 2017;2(10):727-737. doi:10.1016/S2468-1253(17)30253-4
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