About the Therapy GASTRIC ELECTRICAL STIMULATION

WHAT IS GASTRIC ELECTRICAL STIMULATION?

Gastric electrical stimulation with the Medtronic EnterraTM system helps control the chronic nausea and vomiting associated with gastroparesis* by stimulating the smooth muscles of the lower stomach. A small, battery-powered gastric neurostimulator is implanted beneath the skin in the lower abdominal region. Leads deliver mild, controlled electrical pulses to the antrum portion of the stomach muscle wall. The system is programmed to optimize therapy for the individual patient.


HOW GASTRIC ELECTRICAL STIMULATION MAY HELP PATIENTS

Prospective clinical studies show that gastric electrical stimulation may significantly reduce vomiting frequency in patients with gastroparesis of idiopathic or diabetic origin.1

Gastric electrical stimulation may also deliver significant improvement in health-related quality of life.1


ACG RECOMMENDED

The American College of Gastroenterology conditionally recommends gastric electrical stimulation for compassionate treatment in patients with refractory symptoms of gastroparesis, particularly nausea and vomiting.2


RISKS

Enterra Therapy does not work for everyone. Enterra Therapy requires surgery and has risks which may include infection, bleeding, bruising, and pain at the implant site. Adverse events related to the Enterra system may include implant site pain, lead penetration, gastric perforation, bowel obstruction or perforation, lead entanglement or erosion, irritation/inflammation over implant site and device mechanical or electrical problems. Any of these situations may require additional surgery or cause return of symptoms.

Learn more about the probable benefits and risks of this therapy.

To explore whether this therapy may be right for your patient, review the guidelines for patient selection.


FDA-APPROVED AS A HUMANITARIAN USE DEVICE

Gastric electric stimulation with the Medtronic Enterra system is FDA approved.

A humanitarian use device is a medical device intended to treat or diagnose a disease or condition that affects, or is manifest in, fewer than 4,000 individuals a year in the United States. Approval is based on a determination that the device is safe and has probable benefit. Humanitarian use devices must be implanted in a medical center whose institutional review board has approved use of the device. 


*

Humanitarian Device: The effectiveness of this device for this use has not been demonstrated. Learn more about HDE.

A recommendation is graded “conditional” when there is uncertainty about the desirable effects of an intervention outweighing the undesirable effects.


1

Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003; 125:421-28.

2

Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L. Clinical Guideline: Management of Gastroparesis. Am J Gastroenterol. 2013;108:18-37.