Safety Profile

The FDA evaluated IB-Stim for safety in patients (8-21 years) 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.**

0%
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.***

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.***

0%
Incidence of Bleeding at Implantation Site***
0%
Incidence of dermatitis at lead implantation site or generator placement site***
0%
Incidence of Infection at lead implantation site***
0%
Incidence of fainting episodes***