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 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.

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:

  • Use of cardiac pacemakers because no clinical data is available
  • Hemophilia
  • Psoriasis vulgaris

  • A healthy, clean, intact skin surface is essential for the use of IB-Stim stimulator

Warnings & Precautions

  • The built-in microchip creates periods of stimulation and rest. After a time it could feel as if the intensity of the stimulation is decreasing. A decrease in the perceived intensity of stimulation may be subjective and have no bearing on the effectiveness of the therapy.
  • The appliance is splash-proof but not watertight. If desired, hair should be washed before therapy. When showering the appliance must not be allowed to come into direct contact with water.

  • The device should only be applied to healthy, clean, intact skin.

  • Battery is automatically activated and therapy is administered by the device when the wire harness and generator are connected during installation. The device is programed to discontinue therapy 120 hours (5 days) after activation.

Risks

No safety data exists in patients 8-21 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 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.