Important Information for IB-Stim Patients
Indications for Use
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 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 up to 3 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.
DeNovo Number: DEN180057
About The IB-Stim Stimulator
IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient’s ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses.
Contraindications:
Warnings & Precautions
Steri-Strip Warnings
Steri-Strip Precaution
Spillage of compound benzoin tincture into the wound should be avoided, as it may impair the wound healing process.
Risks
No safety data exists in patients 11-18 years of age with IBS treated longer than 4 weeks. Reported side-effects were similar between groups. There were no serious adverse events reported with active treatment. Overall, 10/104 (9.6%) of patients reported side-effects which included mild ear discomfort (n=6; three in the active stimulation group, three in the sham group), adhesive allergy (n=3; one in the IB-Stim group, two in the sham group), and syncope due to needle phobia (n=1; in the sham group).
Testimonials
The testimonials provided are unpaid testimonials from real life IB-Stim patients or parents/guardians. These personal experiences reflect their particular outcome and results may vary from person to person. Please note, these testimonials may include information about technology and intended uses of that technology which may not have 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. 81% of patients in the IB-Stim study had decrease in Global Symptoms. 59% had > 30% reduction in worst pain.
A New Standard Of Care
*The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 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 up to 3 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.