The IB-Stim device uses electrical pulses to stimulate cranial nerves and reduce pain associated with irritable bowel syndrome.
The US Food and Drug Administration (FDA) has decided to permit the marketing of IB-Stim, a medical device that reduces functional abdominal pain in patients 11-18 years old with irritable bowel syndrome (IBS) when used in combination with other treatment for IBS.
The IB-Stim is a single-use electrical stimulator that is placed behind a patient’s ear. The device uses low-frequency electrical pulses to stimulate nerves continuously over the course of 5 days.
The devices may be used for up to 3 consecutive weeks to reduce abdominal pain associated with irritable bowel syndrome.
“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 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 FDA’s decision to permit marketing was supported by results from a clinical trial of 50 patients from 11 to 18 years of age with IBS—27 were treated with IB-Stim and 23 were treated with a sham device. The study measured the change from baseline to the end of 3 weeks of treatment in worst abdominal pain, usual pain, and Pain Frequency Severity Duration (PFSD) scores. Patients continued on stable does of medication throughout the study.
At baseline, worst pain was similar between groups, but the improvement in that measure was better in the active treatment group. The change in worst pain was also better in the treatment group at weeks 1 and 2, compared to the sham treatment group. The active arm also showed greater improvement at week 3 in PFSD scores.
Over half of patients treated with IB-Stim (52%) had at least a 30% decrease in usual pain after 3 weeks compared to 30% of those treated with the sham device.
The IB-Stim is contraindicated for patients with hemophilia, cardiac pacemakers, or psoriasis vulgaris.
The prescription-only device was reviewed through the FDA’s de novo premarket pathway, which is intended for low- to moderate-risk devices that are unique.