Gastric Electrical Stimulation

Gastric Electrical Stimulation

What Is It?

The Enterra Therapy system uses an implanted neurostimulator to generate mild electrical pulses that are sent through insulated wires (leads) to the lower stomach.

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* caused by diabetes or an unknown origin in patients aged 18 to 70 years.

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.

Humanitarian Device

A humanitarian device is a medical device specially designated by the US Food and Drug Administration (FDA) for use in the treatment of a rare medical condition (fewer than 4000 new cases per year in the United States). The FDA requires that any physician who wishes to use the device to treat a patient must first obtain approval from the hospital’s institutional review board. The Medtronic Enterra Therapy system was designated as a device for humanitarian use by the FDA in 1999.

After Enterra Therapy was designated for humanitarian use, Medtronic submitted a Humanitarian Device Exemption (HDE) application to the FDA. This type of application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. However, it must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Also, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that the applicant could not otherwise bring the device to market. Once the FDA approved the Humanitarian Device Exemption in 2000, Medtronic was able to manufacture and distribute Enterra Therapy in the United States.

Next: Enterra II Neurostimulator

*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 to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Our Gastroparesis Product

View photographs, dimensions, and features of the Enterra neurostimulators used for gastric electrical stimulation.

Overview

The Enterra™ II model 37800 gastric neurostimulator is a programmable, implanted device that generates mild electrical pulses to treat chronic, intractable (resistant to medication) nausea and vomiting associated with gastroparesis* caused by diabetes or an unknown origin in patients aged 18 to 70 years.

Key Features

Customized Treatment
Stimulation can be adjusted to the settings that may work for you with a handheld, external programmer used by your doctor.

Reversible
Therapy can be turned off by your doctor at any time if you experience intolerable side effects. In some cases the device may need to be removed.

Placement

The Enterra II system consists of a neurostimulator implanted beneath the skin, usually in the lower abdominal region. Two leads are implanted in the stomach wall muscle layer and connected to the neurostimulator.

Size

Height 2.2″ (55 mm)
Width 2.4″ (60 mm)
Depth 0.5″ (11.4 mm)

The device that appears in this graphic is a representation of a Medtronic device. The graphic does not include certain identifying information that may appear on Medtronic devices, such as model number or serial number.

Next: Probable Benefits and Risks

*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 to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Probable Benefits and Risks

Learn about the probable benefits of gastric electrical stimulation and the risks and complications of the surgical procedure and on-going therapy.

If you have chronic nausea and vomiting from gastroparesis*, and medication has not worked well enough, talk with a specialist about the probable benefits and risks of gastric electrical stimulation and whether this therapy may be right for you.

A clinical study (WAVESS – Worldwide Anti-Vomiting Electrical Stimulation Study1) using the Enterra™ neurostimulator for treating nausea and vomiting has shown that most, but not all, patients have some relief of their vomiting symptoms.

FDA Approved as a Humanitarian Device

Gastric electrical stimulation with the Medtronic Enterra system was approved by the FDA as a humanitarian use device in 2000.

Reversible

Unlike other surgical options, therapy with gastric electrical stimulation is reversible. Using the external clinician programmer, therapy can be turned on and off at any time without surgery. The device can also be removed from the body.

Risks

Gastric electrical stimulation does not work for everyone.

Enterra Therapy requires surgery and has risks. Surgical complications are possible and may include infection, bleeding, bruising, and pain at the implant site.

Adverse events related to the Enterra system may include the following: once implanted, the system may become infected, devices may move or wear through the skin, the lead may entangle with or obstruct the bowel, lead may perforate your stomach, irritation/inflammation over the 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 return of symptoms, and some can be life threatening. For additional safety information, please refer to the Important Safety Information.

Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. August 2003;125(2):421-428.

Next: Questions and Answers

*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 to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.