FDA clears 1st nerve stimulation device for adolescent IBS pain

The first medical device to treat patients aged 11 to 18 for abdominal pain associated with irritable bowel syndrome was cleared for marketing by the FDA earlier this month.

The prescription-only IB-Stim device is a small, battery-powered electrical nerve stimulator that is placed behind the ear and emits low-frequency electrical pulses to stimulate branches of cranial nerves, a technique believed to provide pain relief. The single-use device is worn for five days before being replaced, and can be used consistently for up to three weeks.

The FDA's clearance came after a clinical study showed that adolescent IBS patients who used the device to treat their abdominal pain experienced significant decreases in their pain over the course of three weeks. IB-Stim can be used in tandem with a patient's existing medication regimen for IBS-related chronic abdominal pain.

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