Enterra®-Treatment for gastroparesis:

An innovative solution for chronic nausea and vomiting

If you are one of the many people living with gastroparesis, you have probably tried a variety of treatment options—from dietary changes to medication and beyond—and still struggle to find relief. That is why we developed Enterra® Therapy.

Advantages of Enterra® Therapy

The Enterra® -System is the first and only device specifically designed to gently relieve nausea and vomiting in gastroparesis due to diabetes or unknown causes. It does this through a unique type of therapy called gastric electrical stimulation (GES).
Unlike other surgical treatment options, Enterra® Therapy is:
Implantable
The Enterra® neurostimulator is typically implanted in the lower abdominal region, just under the skin.
Customisable
Your doctor will non-invasively adjust your system to find the right level of stimulation for you.
Reversible
If Enterra® Therapy is not right for you, your doctor can turn off or remove your system.

How does Enterra® Therapy work?

The Enterra®-System consists of three parts:

  1. A small neurostimulator implanted under the skin.
  2. Two wires, known as “leads”, which connect the neurostimulator to the muscles of the stomach.
  3. A handheld external programming device.

Once implanted, the neurostimulator sends gentle electrical impulses through the leads to gently stimulate the smooth muscles of the lower stomach. These impulses are designed to help control the chronic nausea and vomiting associated with gastroparesis.

Using the programming device, your doctor will adjust the neurostimulator to ensure that you receive the right level of stimulation for you. Adjusting your Enterra®-System is non-invasive and does not require surgery.

If you wish, you can ask your doctor to turn off your Enterra®-System without further intervention, or you can opt to have your system surgically removed.

Enterra Neurostimulator

Frequently asked questions

How big is the Enterra® neurostimulator?

The Enterra® II Neurostimulator Model 37800 is 2.4 inches (60 mm) long, 2.2 inches (55 mm) high, and 0.5 inches (11.4 mm) thick. It weighs 1.6 ounces (45 grams).

Enterra® Therapy has completed 4 randomised controlled trials and over 20 years of clinical research. You should talk to your doctor about the clinical data on Enterra® Therapy.

Results vary among patients who experience relief. A combination of different treatment options is often necessary to maintain relief.

The rate of improvement varies from person to person.

The battery life depends on your stimulation settings. Some people require more stimulation, which drains the battery faster, while others require less.

Your doctor will need to schedule surgery to replace the neurostimulator. The Enterra II neurostimulator has a battery indicator that alerts your doctor when it is time to schedule a device replacement for continued therapy.

The entire neurostimulator, including the battery, must be replaced when the battery is empty. The neurostimulator is not rechargeable.

Only your doctor can switch the neurostimulator on and off using the external clinician programming device.

The safety of neurostimulation during pregnancy or childbirth has not been established. If you are pregnant or suspect that you may be pregnant, you should contact your doctor.

IMPORTANT SAFETY INFORMATION

The Enterra® Therapy System for electrical gastric stimulation is intended for the treatment of persistent (drug-resistant) nausea and vomiting due to gastroparesis. In Europe, Enterra® Therapy is indicated for the treatment of chronic, medication-resistant nausea and vomiting associated with gastroparesis in patients aged 18 to 70 years. It is essential that patients always discuss the potential risks and benefits of this treatment option in detail with their treating physician.