By Pat Anson, PNN Editor
The U.S. Food and Drug Administration has cleared for marketing the first medical device to treat abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS).
The IB-Stim device is made by Innovative Health Solutions and is only available by prescription. It uses neuromodulation to stimulate cranial nerves around the ear to provide relief from IBS, a condition affecting the large intestines that causes abdominal pain and discomfort during bowel movements.
The battery powered device is placed behind the patient’s ear — much like a hearing aid — and emits low-frequency electrical pulses that disrupt pain signals. It is intended for use up to three consecutive weeks.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, PhD, director of the FDA’[s Office of Neurological and Physical Medicine Devices.
The FDA reviewed data from a placebo controlled study published in The Lancet that included 50 adolescent patients with IBS. During the study, patients were allowed to continue using medication to treat their abdominal pain. Most had failed to improve through the use of drugs.
IB-Stim treatment resulted in at least a 30% decrease in pain after three weeks in 52% of the treated patients, compared to 30% of patients who received the placebo. Six patients reported mild ear discomfort and three had an allergic reaction caused by an adhesive at the site of application.
Innovative Health Solutions is not disclosing any details about the potential cost of an IB-Stim or where it will be available.
“We are still working to finalize our pricing structure,” Ryan Kuhlman, National Director of Innovative Health Solutions, said in an email. “There are many factors that go into the final contract price with a hospital and will likely vary from hospital to hospital. We do want to make this treatment available and affordable as we work towards favorable insurance coverage.”
The FDA reviewed the IB-Stim through a regulatory pathway for low- to moderate-risk medical devices. Clearance of the device creates a new regulatory classification, which means that similar devices for IBS may be cleared if they are substantially equivalent to an approved device. Similar ear devices have been cleared by the FDA to treat symptoms of opioid withdrawal and for use in acupuncture.
IBS is a group of symptoms that include chronic pain in the abdomen and changes in bowel movements, which may include diarrhea, constipation or both. A 2018 study found that hypnosis relieves pain in about a third of IBS patients.