The FDA evaluated IB-Stim for safety in patients with functional abdominal pain and IBS
The ability of the IB-STIM to produce systemic effects by modulating the central nervous system has been demonstrated in a pre-clinical animal model of “Irritable Bowl Syndrome (IBS)”.
In patients with IBS, the largest effect on all pain measures, including composite pain scores and worst pain was seen after completing 3 consecutive weeks of treatment. A fourth consecutive week of treatment was included in clinical testing; no safety concerns were identified with this extra consecutive week of treatment. In the placebo group, one patient in the placebo group had a fainting episode due to fear of needles.**
Incidence of Dermatitis at lead implantation site or Generator placement site**
Safety of percutaneous electrical nerve field stimulation has also been reported in a separate study of over 1200 patients with no serious adverse events and minimal to no side-effects.***
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A New Standard Of Care
*The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS DEN180057.
