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FDA Approves First Wearable Device for Adolescent IBS Pain
The FDA has approved the IB-Stim non-surgical prescription device (Innovative Health Solutions) to help reduce functional abdominal pain in adolescents with irritable bowel syndrome (IBS) through nerve stimulation.
The device is designed for patients aged between 11 and 18 years. The small, battery-powered device, which is placed behind the ear, continuously emits mild electrical pulses that target certain branches and bundles of cranial nerves. After five days, the device is replaced.
Patients can use the device for up to three consecutive weeks to help reduce the abdominal pain associated with IBS, in combination with other therapies.
The FDA granted the IB-Stim a 510(k) clearance through its de novo product review pathway. The agency had also authorized similar versions of the device, including the NSS-2 Bridge to reduce symptoms of opioid withdrawal, in 2017.
In a clinical study, 50 adolescents with IBS were randomized against a sham treatment. After three weeks, patients who received IB-Stim saw greater improvements compared to baseline scores that measured the frequency, severity, and duration of pain.
Also, 52% of patients reported at least a 30% drop in their usual pain levels over the three weeks, and 59% reported at least a 30% drop in their worst levels of pain.
By comparison, of patients who received the placebo treatment, 30% and 26% reached the same levels in their typical and worst pain scores, respectively.
Source: FierceBiotech, June 11, 2019