Enterra^TM FAQs

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 5 randomized control trials completed and over 20 years of clinical research. You should speak with your doctor regarding the clinical data for Enterra Therapy.

Among the patients that do experience relief, results vary. Often a combination of treatment options is necessary to maintain relief.

The rate of improvement varies from person to person.

How long the battery lasts depends on your stimulation settings. Some people need more stimulation, which drains the battery faster, and others need less.

Your doctor will need to schedule a surgical procedure to replace the neurostimulator. The Enterra II Neurostimulator contains a battery indicator that tells your doctor when it is time to schedule a device replacement for continued therapy.

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

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

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.

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 8000 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 Enterra Therapy System was designated as a device for humanitarian use by the FDA in 1999.

After Enterra Therapy was designated for humanitarian use, a Humanitarian device exemption application was submitted 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, the Enterra Therapy System was then manufactured and distributed in the United States.