An improved neurostimulation system treats chronic, drug-refractory nausea and vomiting associated with gastroparesis of diabetic or unknown origin.

The Medtronic Enterra II System consists of a small neurostimulator implanted under the skin, usually in the lower abdominal region. Two insulated leads are implanted into the stomach wall muscle and connected to the neurostimulator, which then delivers mild electrical pulses to stimulate the smooth muscles of the lower stomach. After the device is implanted, a handheld external programmer is used to noninvasively adjust the neurostimulator and customize the stimulation to each patient's needs.

While the Enterra Therapy has been available to patients since 2000, the new Enterra II System improves the therapy by providing physicians with greater system flexibility and ease of use. The Enterra II features improved programming software, improvements to the system's battery-life indicator, and a customized tool that simplifies implantation of the device for physicians. The Enterra II System is a product of Medtronic (Minneapolis, MN, USA), and has been approved by the US Food and Drug Administration (FDA), under a humanitarian device exemption (HDE).

“Medtronic Enterra Therapy is a well-established treatment option, and we are pleased to make the new Enterra II System available to physicians and patients,” said Linnea Burman, vice president and general manager of gastro/urology therapies at Medtronic. “These therapy enhancements are the latest examples of our ongoing commitment to provide physicians with a therapy that eases life-altering gastroparesis symptoms and enables patients to more comfortably participate in the things they enjoy.”

“Enterra Therapy is an important option for people suffering from the severe effects of gastroparesis, including chronic nausea and vomiting,” said Prof. Henry Parkman, MD, of Temple University (Philadelphia, PA, USA) and director of the GI motility laboratory at Temple University Hospital. “The new advanced system simplifies the implantation process and is easy to program.”

Gastroparesis, also called delayed gastric emptying, is a condition resulting from a partial paralysis of the stomach. This causes the muscles of the stomach and intestines to not properly function; food then moves slowly or not at all through the digestive tract. The condition may occur when the vagus nerve is damaged, but has a number of potential causes, and is particularly associated with diabetes. The condition occurs in about 5% of the diabetic population.

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