TUESDAY, June 11, 2019 -- The IB-Stim has received marketing approval from the U.S. Food and Drug Administration as the first medical device used to help alleviate functional abdominal pain in 11- to 18-year-old patients with irritable bowel syndrome (IBS), the agency announced Friday.
The prescription-only device is composed of a small single-use electrical nerve stimulator placed behind the patient's ear. A battery-powered chip in the stimulator emits low-frequency electrical pulses to continuously stimulate certain cranial nerve branches. The stimulator is replaced after five days, and patients can use the device for up to three consecutive weeks in combination with other IBS therapies.
Marketing approval was based on data from a published clinical study of 50 patients ages 11 to 18 years with IBS. Twenty-seven patients were treated with the device, and the remaining 23 patients received a placebo device. Patients in both groups reported similar worst pain at baseline, and all patients continued stable doses of medication to treat chronic abdominal pain. Fifty-two percent of patients in the treatment group experienced at least a 30 percent reduction in usual pain at three weeks compared with 30 percent of patients who received the placebo device. Fifty-nine percent of treated patients reported at least a 30 percent reduction in worst pain versus 26 percent of patients who received placebo. Patients in the treatment group also had a greater change in composite Pain Frequency Severity Duration scores from baseline to week 3.
Mild ear discomfort was reported for six treated patients, and three patients reported adhesive allergy at the application site. The FDA notes that the IB-Stim is contraindicated for patients with hemophilia, those with cardiac pacemakers, and those diagnosed with psoriasis vulgaris.
Approval of the IB-Stim was granted to Innovative Health Solutions.