The first FDA-approved device to reduce functional abdominal pain in patients 11 to 18 years of age with irritable bowel syndrome (IBS) is now available to medical providers.
The IB-Stim (Innovative Health Solutions) is a prescription-only device comprised of a small single-use electrical nerve stimulator that is placed behind the patient’s ear. Its battery-powered chip emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for 5 days, at which time it is replaced.
Stimulating nerve bundles in and around the ear is thought to provide pain relief. Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS.
“This is a monumental day for the millions of children suffering from functional abdominal pain related to IBS, along with their parents and clinical providers,” said Brian Carrico, CEO of IHS, in a statement from the company. “We know how debilitating this condition can be, and we are proud to release IB-Stim as the first FDA-indicated treatment option for this patient population.”
The FDA based its decision on a double-blind, randomized, controlled trial which was designed to measure the effects of IB-Stim compared to placebo on several aspects of pain including worst pain and the pain-frequency-severity-duration composite score. The study also measured patients’ overall symptom improvement based on the Symptom Response Scale.
Prior to IB-Stim treatment, 70% of patients had failed to improve with an average of 4 medications trialed. Patients treated with IB-Stim demonstrated an 81% improvement in global symptoms with no serious adverse events, and minimal to no side effects, Innovative Health Solutions said.
IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of three weeks in 52% of treated patients compared to 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients compared with 26% of patients who received the placebo, FDA said in a statement.
The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris (a condition in which skin cells build up and form scales and itchy, dry patches).
The FDA reviewed the IB-Stim through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. “This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device,” FDA said.