Dive Brief:

• FDA has given De Novo marketing authorization to the first medical device designed to help reduce abdominal pain in adolescents ages 11 to 18 with irritable bowel syndrome (IBS).
• The IB-Stim device is a small nerve stimulator that is placed behind the patient’s ear to send electrical pulses to targeted cranial nerve bundles. Innovative Health Solutions developed the prescription-only device, which is meant for use in combination with other IBS treatments.
• The Versailles, Indiana-based company sells a similar nerve stimulation platform to alleviate symptoms of opioid withdrawal called the NSS-2 Bridge. That device received FDA clearance in 2017.

Dive Insight:

Nerve stimulation is among the device-based treatment approaches receiving fresh attention for pain management, particularly as an alternative to prescription opioids. The Trump administration has made expanding access to non-opioid pain therapies a priority, and AdvaMed is lobbying for greater reimbursement for device options.

Implanted spinal cord stimulators that target specific nerves with electrical pulses have been used for years to treat chronic pain, mostly in the back and legs. Medtech heavyweights Medtronic, Boston Scientific and Abbott dominate this market.

Innovative Health’s system is part of a new wave of non- and less-invasive technologies targeting nerve activity to address various sources of pain. Others include Theranica Bioelectronics, which is pursuing the migraine market with a patch treatment that received FDA’s De Novo designation last month, and Pacira BioSciences, which in April acquired MyoScience for its FDA-cleared, hand-held device that delivers cold therapy for knee pain relief.

Innovative Health’s device applies electrical stimulation to branches of cranial nerves V, VII, IX and X and the occipital nerves. The single-use IB-Stim device contains a battery-powered chip that sends electrical pulses to the cranial nerves continuously for five days.

Irritable bowel syndrome is a common abdominal condition in children that can cause discomfort, pain and changes in bowel function and contribute to missed school days. It affects an estimated 13% to 38% of adolescents, according to one study.

Innovative Health studied its device in 27 patients ages 11 to 18 for three weeks, finding that the treatment reduced usual pain by 30% in 52% of that group, compared to 30% of the 23 patients who received a placebo, FDA said.