A doctor who offers gastric electrical stimulation can do an evaluation to see if you are a candidate.

Steps in Considering Gastric Electrical Stimulation

1. Get Evaluated – Your doctor will determine appropriate screening tools and diagnostic tests for you. Your doctor may also work with a nutritionist and a nurse to complete an evaluation of your diet.
2. Review the Results – Review the results from screening and testing with your doctor.
3. Discuss Treatment Options – Ask your doctor for a treatment recommendation. Ask questions and review possible side effects of each therapy. Share any concerns you may have with your doctor.
4. Take Action – With your doctor’s help, choose the treatment option that is most appropriate for you. Follow the therapy plan, including diet modification, regular follow-up visits, and other instructions.
5. Seek Prior Authorization – If your doctor determines gastric electrical stimulation is right for you, please ask that he or she obtains prior authorization for gastric electrical stimulation from your health insurance company before the implant.

When Considering Gastric Electrical Stimulation

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

Gastric electrical stimulation is intended to reduce symptoms of chronic intractable (resistant to drugs) nausea and vomiting associated with gastroparesis^* caused by diabetes or an unknown origin in patients aged 18 to 70 years.

However, gastric electrical stimulation is not a cure. The WAVESS (Worldwide Anti-Vomiting Electrical Stimulation Study¹) clinical study has shown that although most patients had some relief from vomiting, it did not work for everyone.

For those patients that do experience a benefit, the rate of improvement will vary from person to person.

Implanting an Enterra™ neurostimulator has risks related to the surgical procedures and risks related to the therapy and device.

In addition to risks related to a medical procedure, complications from gastric electrical stimulation can include implant site pain, infection, stomach wall perforation, lead penetration, lead obstruction of intestines, lead/device problems, irritation/inflammation, uncomfortable/unwanted stimulation, and tissue damage, among others. For a complete list of adverse events, see Important Safety Information.

Often, a combination of treatments is necessary to effectively control symptoms associated with gastroparesis.

If you have an Enterra neurostimulator implanted, there are some medical procedures that you cannot or should not have. Some precautions are necessary around certain electrical and medical equipment and when going through theft detection and security screening gates.

Patients with an implanted neurostimulator and/or lead CANNOT have diathermy of any kind. Patients with an implanted device should not be exposed to magnetic resonance imaging (MRI).

Gastric electrical stimulation is not appropriate for patients who are not candidates for surgical procedures, anesthesia, or both, because of either physical or mental conditions. Gastric electrical stimulation has not been evaluated in pregnant women or in patients younger than age 18 or older than age 70.

Please ask your doctor for more detailed information about Enterra Therapy.

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