FDA Allows Marketing of Medical Device for the Treatment of IBS in Adolescents

The US Food and Drug Administration on June 7 allowed marketing of the first medical device to assist in the reduction of functional abdominal pain among individuals aged 11 to 18 years with irritable bowel syndrome (IBS) when combined with other therapies.

The device, IB-Stim, is a single-use electrical nerve stimulator that produces low-frequency electrical pulses to trigger branches of certain cranial nerves continuously for 5 days.

The FDA allowance comes after a clinical trial comparing the device with placebo (n=50) showed that more than half (52%) of the participants in the device group experienced a decrease of at least 30% in usual pain at the end of 3 weeks compared with 30% of participants in the placebo group. Additionally, 59% of participants in the device group experienced a decrease of at least 30% in worst pain compared with 26% of participants in the placebo group.

A total of 6 participants who received the device reported mild ear discomfort, and 3 reported adhesive allergy at the application site.

“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,” said Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

Reference:

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age [press release]. Silver Spring, MD; US Food and Drug Administration; June 7, 2019. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-medical-device-relief-pain-associated-irritable-bowel-syndrome-patients. Accessed June 10, 2019.