About EnterraTM Therapy
Discover a different kind of treatment
If you’re like many people living with gastroparesis, you’ve tried a number of treatment options—from diet modifications to medications and beyond—and still struggle to find relief. That’s why we developed Enterra™ Therapy.
The Enterra Therapy difference
The Enterra System is the first and only device specifically designed to relieve the nausea and vomiting associated with gastroparesis from diabetes or unknown origins by gently stimulating your stomach — a unique kind of therapy called gastric electrical stimulation (GES).
Unlike other surgical treatment options, Enterra Therapy is:
The Enterra neurostimulator is placed just beneath the skin, usually in the lower abdominal region
Your doctor will non-invasively adjust your system to help find the level of stimulation that’s right for you
If Enterra Therapy isn’t right for you, your doctor can turn off or remove your system
Watch a 3 minute video explaining gastroparesis and Enterra Therapy
How does Enterra Therapy work?
The Enterra System is made up of three parts:
A small neurostimulator that’s implanted under the skin
Two wires, called “leads,” that connect the neurostimulator to the stomach’s muscles
A handheld, external programming device
Once it’s implanted, the neurostimulator sends mild electrical pulses through the leads to gently stimulate the smooth muscles of the lower stomach. These pulses are designed to help control the chronic nausea and vomiting associated with gastroparesis*.
Using the programming device, your doctor will adjust the neurostimulator to help ensure you receive the level of stimulation that’s right for you. Adjusting your Enterra System’s level of stimulation is non-invasive and does not require surgery.
If you choose, you can ask your doctor to turn off your Enterra System, which does not require any additional procedures, or choose to have your system surgically removed.
For more information regarding the risks and side effects associated with receiving an Enterra System, visit the Probable Benefits and Risks page.
Enterra Therapy is a 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 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.
The information provided on this site is for general educational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Always talk to your doctor about the best treatment options for your individual situation.
Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Enterra Medical products is not intended for users in markets that do not have authorization for use.
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IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?