A similar device was developed in 2017 to help alleviate symptoms of opioid withdrawal.
The IB-Stim will look similar to the NSS-2-Bridge seen in the picture above.
(Versailles, Ind.) – A new medical device will help young patients with irritable bowel syndrome (IBS).
Versailles-based Innovative Health Solutions (IHS) has received De Novo approval from the FDA to market a device called IB-Stim.
A first of its kind, the device is a small nerve stimulator that is placed behind the patient’s ear to send electrical pulses to targeted cranial nerve bundles, which helps reduce abdominal pain in adolescents ages 11 to 18 with IBS.
IBS affects an estimated 13 to 38 percent of adolescents, causing discomfort, pain and changes in bowel function that can contribute to missed school days.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “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.”
The IB-Stim is a prescription-only device meant for use in addition with other IBS treatments.
IHS developed a similar device in 2017 to help alleviate symptoms of opioid withdrawal called the NSS-2-Bridge.
For more information, visit www.fda.gov.