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.
The 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
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.
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 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
- 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
- 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