The FDA has approved the first medical device to help reduce abdominal pain in adolescents with irritable bowel syndrome (IBS) through the use of nerve stimulation.
The IB-Stim non-surgical prescription device, developed by Innovative Health Solutions, is designed for patients between 11 and 18 years old. Placed behind the ear, the small, battery-powered device continuously emits mild electrical pulses that target certain branches and bundles of cranial nerves. After five days, the device is replaced.
According to the agency, patients can use the device for up to three consecutive weeks to help reduce functional abdominal pain associated with IBS, alongside other therapies for the syndrome.
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Though the FDA reviewed and granted the IB-Stim a 510(k) clearance through its de novo product review pathway, the agency had previously authorized similar versions of the device. In 2017, the agency approved the NSS-2 Bridge device to reduce the symptoms of opioid withdrawal, and the first such approval was in 2014 as the Electro Auricular Device for use in acupuncture.
In a clinical study, 50 adolescent participants with IBS were randomized against a sham treatment. Those who received the device therapy saw greater improvements compared to baseline pain scores after three weeks in measurements of frequency, severity and duration.
Additionally, 52% of treated patients saw at least a 30% drop in their usual levels of pain over the same time period, while 59% reported at least a 30% drop in their worst levels of pain.
That outpaced the 30% and 26% of patients who reached the same levels while receiving the placebo treatment in their usual and worst pain scores, respectively.