The FDA has granted De Novo clearance to a prescription nerve stimulation device for the reduction of functional abdominal pain. The device is intended for use by adolescents and teens with irritable bowel syndrome in combination with other therapies.
Developed by Innovative Health Solutions, the IB-Stim devices is a single-use electrical nerve stimulator. When placed behind the patient’s ear, it emits low-frequency pulses over the course of five days, after which it can replaced by a new device for up to three consecutive weeks. By doing so, the device stimulates certain cranial nerves that appear to provide pain relief for these patients.
According to the announcement, the agency based its decision on a published clinical study in which 27 patients aged 11 to 18 years were compared to 23 who received a placebo device. Analysis after three weeks found a greater change in pain from baseline among the treatment group, with the effect also present after the first and second week, as well as in composite Pain Frequency Severity Duration scores. Through this study period, six participants reported mild ear discomfort and three reported an adhesive allergy at the site of application.
The IB-Stim device should not be used by those with hemophilia, cardiac pacemakers or a psoriasis vulgaris diagnosis, according to the agency.
WHY IT MATTERS
With the US’ opioid epidemic still in full swing, many are seeking alternative sources of pain relief for various conditions. But beyond this market opportunity for novel nerve stimulation treatments, the IB-Stim fills a key niche among those experiencing abdominal pain.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs.”
WHAT’S THE TREND
In its announcement, the FDA noted two similar stimulation devices that had previously been granted marketing authorization: the NSS-2 BRIDGE, for reducing symptoms of opioid withdrawal, in 2017; and the Electro Auricular Device, for use in acupuncture, in 2014.
More recently, Quell, NeuroMetrix’s wearable, smartphone-friendly chronic pain relief device, received a major facelift with the release of a 2.0 device, while SPR Therapeutics picked up 510(k) clearance for its percutaneous nerve stimulation treatment last summer.
Outside of pain relief, Cala Health closed a $50 million Series C round a few weeks back for its wearable nerve stimulation devices for essential tremor therapy, while Flow launched its brain stimulation headset for UK residents with depression just last week.