Probable Benefits and Risks
Understanding whether Enterra™ Therapy is right for you
If you’re living with chronic nausea and vomiting symptoms of gastroparesis*, Enterra Therapy may help you find relief.
Along with speaking to your doctor, understanding the probable benefits and risks of receiving Enterra Therapy can help you decide if it is right for you.
What to expect from Enterra Therapy
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.
FDA approved as a Humanitarian Device
Gastric electrical stimulation with the 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 without surgery. The device can also be removed from the body.
Risks
Gastric electrical stimulation does not work for everyone.
The Enterra Therapy System 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, the lead may perforate your stomach, or 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.
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.
*HUMANITARIAN DEVICE
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?