ENTERRA THERAPY, Gastric Electrical Stimulation (GES)

NEUROSTIMULATION SYSTEM:
ENTERRA THERAPY, GASTRIC ELECTRICAL STIMULATION (GES)

The Enterra Therapy, Gastric Electrical Stimulation (GES) System (Medtronic, Inc., Minneapolis, MN), is a neurostimulation system indicated for treatment of patients with chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. Gastroparesis is a stomach disorder in which food moves through the stomach more slowly than normal. In some patients, this condition results in severe, chronic nausea and vomiting that cannot be adequately controlled by available drugs. These patients have difficulty eating and may require some form of tube feeding to ensure adequate nutrition. Enterra Therapy uses mild electrical pulses to stimulate the stomach. This electrical stimulation helps to control the symptoms associated with gastroparesis, including nausea and vomiting.

Enterra Therapy has been used successfully in people for several years. Worldwide clinical trials have been conducted in patients with severe symptoms of nausea and vomiting associated with gastroparesis. The results (Medtronic FDA Application H990014) showed that the therapy successfully reduced symptoms of nausea and vomiting in patients for whom drug treatments did not work.

Patients also experienced improvements in other upper GI symptoms, solid food intake, and a reduction in hypoglycemic attacks, as well as significant improvements in health related quality of life.


Enterra Models: 7425G, 3116

Patients with an implanted device should not be exposed to the electromagnetic fields produced by magnetic resonance imaging (MRI). Use of MRI may potentially result in system failure or dislodgment, heating, or induced voltages in the neurostimulator and/or lead. An induced voltage through the neurostimulator or lead may cause uncomfortable, "jolting" or "shocking" levels of stimulation.

Clinicians should carefully weigh the decision to use MRI in patients with an implanted neurostimulation system, and note the following:
-Magnetic and radio-frequency (RF) fields produced by MRI may change the neurostimulator settings, activate the device, and injure the patient.
-Patients treated with MRI should be closely monitored and programmed parameters verified upon cessation of MRI.

[MRI healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MRI procedure.]

REFERENCE
www.Medtronic.com