The U.S. Food and Drug Administration today permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. IBS is a condition affecting the large intestines that can cause abdominal pain and discomfort typically related to bowel movements.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, Ph.D., 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.”
The IB-Stim is a prescription-only device comprised of a small single-use 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 five 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 three consecutive weeks to reduce functional abdominal pain associated with IBS.
IBS is a group of symptoms that occur together, including repeated pain in the abdomen and changes in bowel movements, which may be diarrhea, constipation or both. With IBS, the symptoms can be present without any visible signs of damage or disease in the digestive tract…