Innovative Health’s IBS Nerve Stimulator Cleared

FDA has cleared an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. “This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” an FDA news release says.

The prescription-only device comprises a small single-use electrical nerve stimulator that is placed behind a 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, at which time it is replaced,” the agency says. “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.”