News

Marketing of IBS Device Is a Go

Jun 14, 2019

The US Food and Drug Administration (FDA) has approved the marketing of a device to help with irritable bowel syndrome (IBS) pain.

This device is designed to help reduce stomach pain due to IBS. It is intended for adolescents between the ages of 11 and 18.

This device is found under the name IB-Stim. According to the FDA, this device is to be combined with other therapies used to treat IBS.

IBS affects the large intestine. IBS can cause stomach cramping, bloating and a change in bowel habits, which can include diarrheaconstipation or both.

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Dr. Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a press release.

This device is only available as a prescription. It is made up of an electrical nerve stimulator that is placed behind the ear. It gives off low-frequency electrical pulses to stimulate branches of certain cranial nerves. Stimulating nerve bundles in and around the ear is thought to provide pain relief.

The device can be used for up to three weeks, the FDA noted.

IB-Stim is not for everyone. Those with cardiac pacemakers, hemophilia or psoriasis vulgaris (a skin condition in which the buildup of skin cells forms scales and itchy, dry patches) are not to use this device.

The FDA granted marketing approval of this device to Innovative Health Solutions.

Discuss any concerns or questions about IBS with your health care provider.

Written by Anyssa Garza, PharmD, BCMAS

Read More