IB-Stim

The US FDA has endorsed percutaneous electrical nerve field stimulation as a treatment for functional abdominal pain in adolescents with irritable bowel syndrome (IBS).

The FDA’s action permits marketing of IB-Stim – the first medical device to aid in the reduction of IBS symptoms.

IB-Stim is a prescription-only device comprising a small single-use electrical nerve stimulator that is placed behind the patient’s ear.

Patients can use the device for up to three consecutive weeks to reduce functional abdominal pain associated with IBS in conjunction with usual pharmacotherapies.

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Dr 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.”

The FDA approval is based on evidence from a randomised sham-controlled study of patients aged 11-18 years.

The study found worst pain and Pain Frequency-Severity-Duration (PFSD) scores improved in the treated group compared to the sham group after three weeks of treatment.

IBS expert Professor Nick Talley, from the University of Newcastle, told the limbic the device was certainly a novel approach to IBS but one study does not establish efficacy.

“The results need to be reproduced to be convincing. And the long-term outcomes are unclear.”

He said if electrical field stimulation works in adolescents, it was likely that adults might also benefit – but that this also needs testing.

The FDA said the device was contraindicated for patients with haemophilia, cardiac pacemakers or those diagnosed with psoriasis vulgaris.