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Gastroparesis Institute of USC

Enterra Therapy for Gastroparesis

Gastric Electrical Stimulation for Gastroparesis

Enterra Therapy is designed to improve chronic, drug-refractory nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin.

Enterra Therapy for GastroparesisThe Enterra Therapy system consists of a neurostimulator (about the size of a pocket watch: 2.2” high x 2.4” long x 0.4” thick) implanted beneath the skin, usually in the lower abdominal region. Two leads (insulated wires) are implanted in stomach 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 helps to control the chronic nausea and vomiting caused by gastroparesis.

During an office visit, the doctor uses a handheld, external programmer to adjust the neurostimulator and customize therapy for each patient. This is done without surgery. The therapy can be turned off by the doctor at any time if a patient experiences any intolerable side effects.

Enterra Therapy received Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration (FDA) in 2000. HDE status allows Medtronic, Inc. to provide Enterra Therapy for the treatment of drugrefractory nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin. The effectiveness for the labeled indication 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.

Enterra Therapy implanted
Above: The implanted Enterra Therapy System


Things to Consider Before Choosing Enterra Therapy

If your doctor determines that you are a candidate for Enterra Therapy, before making a decision about your treatment, please consider the following:

  • The therapy is intended to reduce symptoms of chronic nausea and vomiting associated with gastroparesis of idiopathic or diabetic origin that resists treatment with medication. However, Enterra Therapy is not a cure.
  • Improvements in symptoms may be gradual or immediate. The rate of improvement varies from person to person.
  • Implanting an Enterra Therapy system has risks and side effects. Surgical complications are possible and may include infection, bleeding, bruising, and pain at the implant site. Once implanted, the system may become infected, devices may move or wear through the skin, the lead may entangle with or obstruct the bowel, irritation/inflammation over implant site may occur. The therapy system could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return.
  • Most often, a combination of Enterra Therapy, diet modification, and medication is necessary to effectively control symptoms of gastroparesis.
  • If you have an Enterra Therapy system implanted, some precautions are necessary around certain electrical and medical equipment and when going through theft detection and security screening gates.
  • Enterra Therapy is not appropriate for patients who are not candidates for surgical procedures and/or anesthesia because of physical or mental conditions.
  • Enterra Therapy should not be used for patients who will be exposed to diathermy (deep heat treatment).
  • Enterra Therapy has not been evaluated in pregnant women or in patients younger than age 18 or older than age 70.


Next: Surgical Treatment for Gastroparesis

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USC Gastroparesis Institute
1510 San Pablo St., Suite 514
Los Angeles, CA 90033

Phone: (323) 442-6868

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