The first medical device for patients 11-18 years old with Irritable Bowel Syndrome (IBS) has received Food and Drug Administration permission for marketing. The IB-Stim would be used in combination with other IBS therapies. IBS causes symptoms including, but not limited to, changes in bowel movements and pain in the abdomen.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation," said Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health. “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.”
IB-Stim is a device with a small single-use electrical nerve stimulator placed behind the patient’s ear. The low-frequency electrical pulses stimulate nerve bundles to possibly provide pain relief. A study with 50 patients 11-18 years old was reviewed by the FDA. In the study, 27 people were given the device to measure changes from baseline in abdominal pain.
The device was reviewed by the FDA through the de novo premarket review and marketing authorization for the IB-Stim was granted to Innovative Health Solutions.
