The US Food and Drug Administration (FDA) has permitted Innovative Health Solutions to market the medical device to help reduce functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS), in combination with other therapies for IBS.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
IBS is a condition that affects large intestines, showing a group of symptoms that occur together, causing repeated abdominal pain and discomfort in relation to changes in bowel movements.
The company said that with IBS, the symptoms can be present without any visible signs of damage or disease in the digestive tract.
Comprising a small single-use electrical nerve stimulator that is placed behind the patient’s ear, the IB-Stim is a prescription-only medical device that stimulates nerve bundles in and around the ear to provide pain relief.
IB-Stim is equipped with a battery-powered chip that emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for five days, at which time it is replaced. Use of IBS for up to three consecutive weeks would reduce functional abdominal pain.
FDA Neurological and Physical Medicine Devices director Carlos Peña said: “This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation.
“Today’s action reflects our ongoing commitment to advancing the development of paediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs.”
FDA said that it has reviewed data form a clinical study that included 50 patients between 11-18 years of age with IBS. Out of 50 patients, 27 were treated with the device and 23 received a placebo device.
The study has calculated the change in worst abdominal pain, usual pain and Pain Frequency Severity Duration (PFSD) scores, which incorporate multiple aspects of pain experience.
Under the study, patients were given stable doses of chronic abdominal pain medication and the study showed that the pain at baseline was similar between the treatment and placebo groups.
The treatment using IB-Stim device resulted in at least a 30% decrease in usual pain at the end of three weeks in 52% of treated patients compared to 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients compared with 26% of patients who received the placebo.
IB-Stim is not advised for patients with haemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris, a condition in which skin cells build up dry patches and form scales and itchy.