A medical device to relieve functional abdominal pain in patients with irritable bowel syndrome (IBS) has been approved for marketing by the Food and Drug Administration (FDA).
The IB-Stim is a prescription-only, percutaneous electrical nerve field stimulator (PENFS) system intended to be used by patients 11 to 18 years of age. The device consists of a single-use nerve stimulator placed behind the ear that emits a low-frequency electrical pulse to stimulate branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. It is intended to be used for 120 hours per week up to 3 consecutive weeks; the device is programmed to discontinue treatment 5 days after activation.
The marketing authorization was granted to Innovative Health Solutions. The Agency reviewed data from a post-hoc sub-group analysis of 50 adolescent patients with IBS which specifically looked at reduction of abdominal pain; participants were allowed to continue pharmacological therapies for their chronic abdominal pain during the study. The primary endpoint was change in abdominal pain scores using the Pain Frequency-Severity-Duration (PFSD) scale.
Results showed that IB-Stim treatment was associated with a ≥30% decrease in usual pain at the end of 3 weeks in 52% of treated patients compared with 30% of patients who received placebo; 59% of treated patients had a ≥30% decrease in worst pain compared with 26% of those who received placebo.
The device is contraindicated in patients with cardiac pacemakers and in those with hemophilia or psoriasis vulgaris; healthy, clean, intact skin is necessary for IB-Stim use.
“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 at the FDA.
For more information visit ibstim.com.