FDA Approves Marketing of First IBS Device for Certain Pediatric Patients
This week FDA granted marketing authorization to Innovative Health Solutions’ IB-Stim device to held reduce functional abdominal pain in pediatric irritable bowel syndrome (IBS) patients 11–18 years old.
The prescription-only single-use electrical nerve stimulator is to be used in conjunction with other IBS therapies. It is comprised of a battery-powered chip that emits low-frequency electrical pulses that continuously stimulates branches of specific cranial nerves for five days. The device is placed behind the ear, stimulating nerve bundles in and around the ear. It can be used up to three weeks to reduce functional abdominal pain related to IBS.
“This is a monumental day for the millions of children suffering from functional abdominal pain related to IBS, along with their parents and clinical providers,” said Brian Carrico, CEO of Innovative Health Solutions in a company press release. “We know how debilitating this condition can be, and we are proud to release IBStim as the first FDA indicated treatment option for this patient population.”
The IB-Stim is contraindicated for patients who have hemophilia, cardiac pacemakers, or have been diagnosed with psoriasis vulgaris. FDA reviewed it via the de novo premarket review pathway.
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