The FDA reported last week that it permitted marketing of the first medical device to reduce functional abdominal pain in patients ages 11-18 with irritable bowel syndrome.
The U.S. regulatory body said the IB-Stim device, made by Innovative Health Solutions, could be used by this patient population when combined with other IBS therapies.
The device features a small, single-use electrical nerve stimulator that is placed behind a user’s ear. The device contains a chip that gives off low-frequency electrical pulses, stimulating branches of certain cranial nerves continuously for five days, according to the FDA.
In reviewing the IB-Stim device, the FDA looked at data from a 50-person clinical study. The study evaluated change from baseline to the end of three weeks in abdominal pain, usual pain and pain frequency severity duration scores.
An analysis showed a greater improvement in the worst pain from baseline to week three in the treatment group compared to the placebo group, according to the FDA. Use of the IB-Stim device also resulted in a 30% decrease in usual pain at the end of three weeks in 52% of treated patients.
Innovative Health Solutions’ product is contraindicated for people with hemophilia, cardiac pacemakers or psoriasis vulgaris, the FDA reported.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in prepared remarks.
“Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs,” he added.
