TUESDAY, June 11, 2019 (HealthDay News) – The IB-Stim has received marketing approval from the US Food and Drug Administration as the first medical device used to relieve functional abdominal pain in 11- to 18-year-old patients with irritable bowel syndrome (IBS) ), the agency announced on 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 transmits low-frequency electrical pulses to constantly 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 aged 11 to 18 with IBS. Twenty-seven patients were treated with the device and the remaining 23 patients received a placebo device. Patients in both groups reported the same worst baseline pain and all patients continued with stable doses of medication to treat chronic abdominal pain. Fifty-two percent of patients in the treatment group experienced at least 30 percent reduction in the usual pain after three weeks compared to 30 percent of patients receiving the placebo device. Fifty-five percent of the patients treated reported a reduction of at least 30 percent of the worst pain compared to 26 percent of patients receiving placebo. Patients in the treatment group also had a greater change in the composite PF Duration Severity Duration scores from baseline to week 3.
Mild ear disorders were reported in 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 haemophilia, patients with pacemakers, and patients diagnosed with psoriasis vulgaris.
Approval of the IB-Stim was granted to Innovative Health Solutions.
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(tagsToTranslate) Marketing OKed for device to reduce IBS symptoms in adolescents