WASHINGTON — The FDA announced Friday that it will permit marketing of the first medical device to help reduce functional abdominal pain in patients ages 11 to 18 with irritable bowel syndrome (IBS) when combined with other IBS therapies.
The IB-Stim device, a small electrical nerve stimulator placed behind a patient’s ear, emits low-frequency electrical pulses to stimulate cranial nerve branches continuously for 5 days. This stimulation targets brain areas involved in processing pain and helps reduce functional abdominal pain associated with IBS, according to device maker Innovative Health Solutions.
“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 a statement.
The FDA reviewed data from a clinical study of 50 IBS patients who were ages 11 to 18: 27 were treated with IB-Stim and 23 were treated with a placebo device. During the study, patients were allowed to continue stable doses of medication to treat chronic abdominal pain.
The study measured change from baseline to the end of the third week in worst abdominal pain, usual pain, and Pain Frequency Severity Duration (PFSD) scores. A repeated measures analysis showed a greater improvement in worst pain from baseline to week 3 in the treatment group, an effect that also was seen at weeks 1 and 2. Composite PFSD scores from baseline to week 3 in the IB-Stim group also improved more than in placebo, as did usual pain, the FDA said.
The IB-Stim device is intended to be used for 120 hours per week up to 3 consecutive weeks. It is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or people diagnosed with psoriasis vulgaris.
Similar versions of this device previously received FDA marketing authorization to help reduce opioid withdrawal symptoms and for use in acupuncture. The FDA reviewed the IBS application under its so-called de novo premarket review pathway for novel devices with low to moderate risk.