The U.S Food and Drug Administration (FDA) has approved marketing of the IB-Stim device, for use in adolescents, ages 11-18, with functional gastrointestinal pain related to irritable bowel syndrome (IBS).
IB-Stim, developed by Innovative Health Solutions in Indiana, is a small nerve stimulator device powered by a battery and intended to be worn behind the ear. The FDA approval was based on a randomized, double-blind clinical trial of 50 youth in the approved age range. According to Innovative Health Solution’s results, 81% of the study participants in the IB-Stim group experienced a reduction in symptoms with minimal or no side effects. Reportedly,70% had previously not obtained adequate relief with an average of four medications.
Each IB-Stim device will be available by prescription only, and is to be used for five days at a time and then replaced. The FDA approval clears the device to be worn safely for up to 120 hours over three consecutive weeks. IB-Stim was used in clinical trial as an addition to medication, not as the only intervention. It is considered medically inappropriate for children with hemophilia, cardiac pacemakers or psoriasis vulgaris.
IBS Impact encourages adolescents with IBS and their parents or guardians to educate themselves fully from reputable, evidence-based sources on this new option. As individuals’ medical history and response to any treatment will vary, informed decisions as to if the IB-Stim is safe and appropriate for a specific youth should be made in consultation with the child’s own physician.
Stimulation Device for Pediatric IBS Pain Wins FDA Nod (MedPage Today)
FDA permits marketing of first IBS device for patients 11-18 years old (Healio Primary Care)
FDA clears device to treat pain in youth with IBS (New England Journal of Medicine, Journal Watch)
Many adults and children with IBS experience pain as one of their most disabling IBS symptoms. Also, historically, evidence-based IBS treatment options for children and teenagers have been even more limited than for adults because of various factors related to their age group. Thus, IBS Impact welcomes this ground-breaking new development and will be watching further news of this treatment option closely as it becomes publicly available for prescription. We hope that in wider use, it will continue to fulfill its apparent promise in providing safe, effective pain relief to many adolescents with IBS.
Posted: June 2019