The US Food and Drug Administration (FDA) has approved the first medical device to help reduce functional abdominal pain in patients aged 11 to 18 years with irritable bowel syndrome (IBS), when used in conjunction with other IBS therapies. The prescription-only IB-Stim device, from Innovative Health Solutions, consists of a small electrical nerve stimulator that is placed behind the patient's ear. It contains a battery-powered chip that 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, the FDA said in a news release. "This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation," Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, said in the release. In clearing the IB-Stim, the FDA reviewed data from a study of 50 patients 11 to 18 years old with IBS in which 27 used the device and 23 used a placebo device. Patients were allowed to continue stable doses of medication to treat chronic abdominal pain. Worst pain at baseline was similar between the IB-Stim and placebo groups. A repeated measures analysis showed a greater improvement in worst pain from baseline to week 3 in the IB-Stim group. This effect was also seen in the first 2 weeks, the FDA said. Greater improvement was also demonstrated in composite Pain Frequency Severity Duration scores from baseline to week 3 in the IB-Stim group compared with the placebo group. Use of the IB-Stim device led to at least a 30% decrease in usual pain at the end of 3 weeks in 52% of treated patients compared with 30% of patients in the placebo group, and at least a 30% decrease in worst pain in 59% of IB-Stim patients compared with 26% of placebo patients. The device should not be used in patients with hemophilia, cardiac pacemakers, or those diagnosed with psoriasis vulgaris. 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. The FDA cleared similar versions of this device for other uses — namely, the NSS-2 BRIDGE cleared in 2017 as an aid to reduce the symptoms of opioid withdrawal and the Electro Auricular Device (now called Bridge Neurostimulation System) in 2014 for use in acupuncture. Source
