This page discusses ongoing research activities with percutaneous electrical nerve field stimulator (PENFS) technology. This information is intended for healthcare providers, who may have interest in furthering research and development with PENFS as well as payors, government bodies and review committees, who are seeking information about the product to help them make their own decisions, on a case by case basis about coverage, only. Please note, the research being described may include information about technology and intended uses of that technology which have not been reviewed or approved/cleared by the U.S. FDA, and is being provided for informational purposes only. NeurAxis does not recommend or suggest the use of its PENFS IB-Stim device for uses beyond those that are cleared by the U.S. FDA.
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.