Probable Benefits and Risks ENTERRA 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.

 


1

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


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.