• 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
    • Strategic Plan, 2020-2023
    • Committees
      • Descriptions and Video Updates
      • 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
      • 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
    • COVID-19 Announcements
    • SAGES 2020 Meeting Information
    • 2021 Scientific Session Call For Abstracts
    • 2021 Emerging Technology Session Call For Abstracts
    • 2018 Prevent BDI Consensus Conference
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Past Meetings
      • Leadership Development and Health Policy Conference Videos
      • SAGES Quality Summit Meeting
      • SAGES 2019
      • SAGES 2018
      • SAGES 2017
      • SAGES 2016
      • SAGES 2015
      • SAGES 2014
      • SAGES 2013
    • Related Meetings Calendar
  • Membership
    • 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
    • COVID-19 Annoucements
    • 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
    • Troubleshooting Guides
  • Education
    • SAGES.TV Video Library
    • Virtual Hernia Clinic
    • The SAGES Safe Cholecystectomy Program
    • The 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
    • The SAGES HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Endorsed Courses
    • SAGES Robotics Fellows Courses
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Educational Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES Quality Initiative
    • 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
    • SAGES Research Opportunities
    • SAGES Endorsed Courses
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
    • Fellowship Certification
  • Search
    • COVID-19 Announcements
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • Blog
    • All Blog Posts
    • COVID-19
    • Notes from the Battlefield
    • A (Positive) Way Forward
    • President Posts
  • 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

Post Views: 845

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

Newsletter Subscription

  • This field is for validation purposes and should be left unchanged.

Important Links

SAGES 2020 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

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

[footer_backtotop] · Log in

Copyright © 2021 Society of American Gastrointestinal and Endoscopic Surgeons · Legal
· Managed by BSC Management, Inc