Research & Development
The US FDA approves the marketing of first medical device IB-Stim for relief of pain associated with irritable bowel syndrome
10 June 2019 -

Public health agency The US Food and Drug Administration announced on Friday that it authorised the marketing of the first medical device IB-Stim through the de novo premarket review pathway for the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.

IBS is a condition affecting the large intestines that can cause abdominal pain and discomfort typically related to bowel movements. IBS is a group of symptoms that occur together, including repeated pain in the abdomen and changes in bowel movements, which may be diarrhoea, constipation or both.

The US FDA granted the marketing authorisation of the IB-Stim to Innovative Health Solutions.

According to the agency, the IB-Stim is a prescription-only device comprised of a small single-use electrical nerve stimulator that is placed behind the patient's ear. It contains a battery-powered chip that emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for five days. Stimulating nerve bundles in and around the ear is thought to provide pain relief. Patients can use the device for up to three consecutive weeks to reduce functional abdominal pain associated with IBS.

In conjunction, the agency reviewed data from a published clinical study that included 50 patients 11-18 years of age with IBS, under which, 27 patients were treated with the device and 23 patients received a placebo device.

Under the study, IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of three weeks in 52% of treated patients compared to 30% of patients who received the placebo and at least a 30% decrease in worst pain in 59% of treated patients compared with 26% of patients who received the placebo, concluded the agency.

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