• Skip to primary navigation
  • Skip to main content
  • Skip to footer

SAGES

Reimagining surgical care for a healthier world

  • Home
    • COVID-19 Annoucements
    • Search
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Who is SAGES?
    • SAGES Mission Statement
    • Advocacy
    • Strategic Plan, 2020-2023
    • Committees
      • Request to Join a SAGES Committee
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Full Committee Rosters
      • SAGES Past Presidents
    • Donate to the SAGES Foundation
    • Awards
      • George Berci Award
      • Pioneer in Surgical Endoscopy
      • Excellence In Clinical Care
      • International Ambassador
      • IRCAD Visiting Fellowship
      • Social Justice and Health Equity
      • Excellence in Community Surgery
      • Distinguished Service
      • Early Career Researcher
      • Researcher in Training
      • Jeff Ponsky Master Educator
      • Excellence in Medical Leadership
      • Barbara Berci Memorial Award
      • Brandeis Scholarship
      • Advocacy Summit
      • RAFT Annual Meeting Abstract Contest and Awards
  • Meetings
    • NBT Innovation Weekend
    • SAGES Annual Meeting
      • 2023 Scientific Session Call For Abstracts
      • 2023 Emerging Technology Call For Abstracts
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Past Meetings
      • SAGES 2022
      • SAGES 2021
    • Related Meetings Calendar
  • Join SAGES!
    • Membership Benefits
    • Membership Applications
      • Active Membership
      • Affiliate Membership
      • Associate Active Membership
      • Candidate Membership
      • International Membership
      • Medical Student Membership
    • Member News
      • Member Spotlight
      • Give the Gift of SAGES Membership
  • Patients
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Patient Information Brochures
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find a SAGES Member
  • Publications
    • SAGES Stories Podcast
    • SAGES Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Patient Information Brochures
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • SAGES Manuals
    • SCOPE – The SAGES Newsletter
    • COVID-19 Annoucements
    • Troubleshooting Guides
  • Education
    • OpiVoid.org
    • SAGES.TV Video Library
    • Safe Cholecystectomy Program
      • Safe Cholecystectomy Didactic Modules
    • Masters Program
      • SAGES Facebook Program Collaboratives
      • Acute Care Surgery
      • Bariatric
      • Biliary
      • Colorectal
      • Flexible Endoscopy (upper or lower)
      • Foregut
      • Hernia
      • Robotics
    • Educational Opportunities
    • HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Video Based Assessments (VBA)
    • Robotics Fellows Course
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES OR SAFETY Video
    • SAGES at Cine-Med
      • SAGES Top 21 MIS Procedures
      • SAGES Pearls
      • SAGES Flexible Endoscopy 101
      • SAGES Tips & Tricks of the Top 21
  • Opportunities
    • NEW-Area of Concentrated Training Seal (ACT)-Advanced Flexible Endoscopy-Coming Soon!
    • SAGES Fellowship Certification for Advanced GI MIS and Comprehensive Flexible Endoscopy
    • Multi-Society Foregut Fellowship Certification
    • SAGES Research Opportunities
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
  • Search
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • Store
    • “Unofficial” Logo Products
  • Log In

IB-Stim

January 21, 2020 by Benjamin Reed

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 [1].

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.

References:

  1. 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

Image by Innovative Health Solutions

2,392

Share this:

  • Twitter
  • Facebook
  • LinkedIn
  • Pinterest
  • WhatsApp
  • Reddit

Related

Contact SAGES

Society of American Gastrointestinal and Endoscopic Surgeons
11300 W. Olympic Blvd Suite 600
Los Angeles, CA 90064 USA
webmaster@sages.org
Tel: (310) 437-0544

Find Us Around the Web!

  • Facebook
  • Twitter
  • YouTube

Important Links

SAGES 2023 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

  • taTME Study Info
  • Foundation
  • SAGES.TV
  • MyCME
  • Educational Activities

Copyright © 2023 Society of American Gastrointestinal and Endoscopic Surgeons