Questions and Answers – Neurostimulation

How large is the Enterra neurostimulator?

The Enterra^® neurostimulator is 2.4 inches (60 mm) long, 2.2 inches (55 mm) high, and 0.4 inches (10 mm) thick. It weighs 1.5 ounces (42 grams).

Will the Enterra neurostimulator eliminate my nausea and vomiting symptoms?

The WAVESS (Worldwide Anti-Vomiting Electrical Stimulation Study) clinical study of the Enterra neurostimulator used in treating nausea and vomiting has shown that most, but not all, patients have some relief of their vomiting symptoms.

If gastric electrical stimulation works for me, when will I notice improvements in my symptoms?

The rate of improvement varies from person to person.

How long will my neurostimulator battery last?

How long the battery lasts depends on your stimulation settings. Some people need more stimulation, which drains the battery faster, and others need less. The battery life is estimated to be 5 to 10 years.

What will happen when the neurostimulator battery runs down?

When the battery runs down, the therapeutic effect may be altered. Your doctor will need to schedule a surgical procedure to replace the neurostimulator.

Can the neurostimulator battery be recharged?

The entire neurostimulator, which contains the battery, must be replaced when the battery runs down. The neurostimulator is not rechargeable.

Will I be able to turn the neurostimulator on and off?

Only your doctor can turn the neurostimulator on and off with the external clinician programmer.

Can the Enterra neurostimulator be used during pregnancy?

The safety of neurostimulation for use during pregnancy or delivery has not been established. If you learn, or suspect, that you are pregnant, call your doctor.

What is a Humanitarian Use Device (HUD)?

The HUD regulations were first established in October 1994. Humanitarian Use Devices (HUDs) are medical devices specially designated by the FDA for use in the treatment of rare medical conditions (<4000 per year). The Medtronic Enterra Therapy system was designated a humanitarian Use Device by the FDA in the fall of 1999, and approval of the Humanitarian Device Exemption allows Medtronic to manufacture and distribute this Humanitarian Use Device. Physicians who wish to use the Enterra Therapy under HUD guidelines must first obtain approval from their hospital Internal Review Board (IRB).

An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, 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. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

http://www.accessdata.fda.gov

What is Humanitarian Device Exemption (HDE)?

Enterra Therapy received humanitarian device exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) in 2000. HDE status allows Medtronic, Inc. to provide the Enterra Therapy System for the treatment of drug-refractory nausea and vomiting associated with gastroparesis of diabetic or idiopathic origin. 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.

Next: Getting a Device

Humanitarian Device: The effectiveness of this device for this use has not been demonstrated.

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.

Last updated: 3 Aug 2008