USFDA okays marketing of first medical device IB-Stim to treat IBS pain
The IB-Stim is a prescription-only medical device comprised of a small single-use electrical nerve stimulator that is placed behind the patient’s ear.
New Delhi: The U.S. Food and Drug Administration(USFDA) recently permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.
IBS is a condition affecting the large intestines that can cause abdominal pain and discomfort typically related to bowel movements.
Commenting on the approval, Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health 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 pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs, ” Carlos added.
The IB-Stim is a prescription-only device comprised of a small single-use electrical nerve stimulator that is placed behind the patient’s ear. It contains 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. Stimulating nerve bundles in and around the ear is thought to provide pain relief. Patients can use the device for up to three consecutive weeks to reduce functional abdominal pain associated with IBS.
IBS is a group of symptoms that occur together, including repeated pain in the abdomen and changes in bowel movements, which may be diarrhoea, constipation or both. With IBS, the symptoms can be present without any visible signs of damage or disease in the digestive tract.
The USFDA reviewed data from a published clinical study that included 50 patients 11-18 years of age with IBS - 27 patients were treated with the device and 23 patients received a placebo device.
The device is contraindicated for patients with haemophilia, patients with cardiac pacemakers or those diagnosed with psoriasis vulgaris (a condition in which skin cells build up and form scales and itchy, dry patches).
The FDA reviewed the IB-Stim through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
Similar versions of this device for other uses were previously granted marketing authorization by the FDA. The NSS-2 BRIDGE was permitted for marketing in 2017 as an aid to reduce the symptoms of opioid withdrawal. The FDA first cleared a version of the device, known as the Electro Auricular Device, in 2014 for use in acupuncture.
The USFDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.