What Is Gastric Electrical Stimulation?

The Enterra^® neurostimulator

With gastric electrical stimulation, a small device (neurostimulator) is implanted beneath the skin, usually in the lower abdominal region. Two leads (insulated wires) are implanted in the stomach wall muscle and then connected to the neurostimulator. The surgical procedure is performed under general anesthesia.

The neurostimulator sends mild electrical pulses through the leads to stimulate the nerves and smooth muscles of the lower stomach. This may help to control the chronic nausea and vomiting caused by gastroparesis.

After the device is implanted, the doctor uses a handheld, external programmer to adjust the neurostimulator and customize the stimulation for each patient. Stimulation can be adjusted without surgery. The stimulation can be turned off by the doctor at any time if a patient experiences any intolerable side effects.

The Enterra neurostimulator received humanitarian device exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) in 2000. HDE status allows Medtronic, Inc. to provide the Enterra System for the treatment of chronic drug-refractory nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin. However, the effectiveness of gastric electrical stimulation for this use has not been demonstrated.

Because of the HDE status, the system must be implanted in a medical center whose institutional review board (IRB) has approved use of the device.

Next: Enterra Neurostimulator

Humanitarian Device: The effectiveness of this device for this use has not been demonstrated.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 3 Aug 2008