The Enterra Therapy system uses an implanted neurostimulator to generate mild electrical pulses through insulated wires (leads) to the lower stomach.
Enterra™ Therapy may help to control symptoms of chronic nausea and vomiting associated with gastroparesis caused by diabetes or unknown origin in patients aged 18-70 years.
Humanitarian Device: The Enterra Therapy system for gastric electrical stimulation is authorized by Federal law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary togastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?
A small medical device called a neurostimulator is implanted under the skin, usually in the lower abdominal region. Two insulated wires called leads are implanted in the stomach wall muscle and then connected to the neurostimulator. The procedure is performed under general anesthesia.
The neurostimulator sends mild electrical pulses through the leads to stimulate the smooth muscles of the lower stomach. This may help to control the chronic nausea and vomiting associated with gastroparesis when it cannot be controlled by medication.
After the device is implanted, the doctor uses a handheld, external programmer to adjust the neurostimulator and customize the stimulation. Stimulation can be adjusted without surgery. The stimulation can be turned off by the doctor at any time if the person experiences any intolerable side effects.
Refer to Probable Benefits and Risks for risk and side effect details regarding implantation of an Enterra™ system.