- The Washington Times - Monday, October 13, 2003

FORT LAUDERDALE, Fla. (AP) — An implanted electrical device that fools the body into feeling full, a kind of pacemaker for the tummy, appears to be an effective alternative to radical digestive surgery for obese people.

If it proves effective in larger studies, the experimental device could offer a new way to help obese people slim down when they cannot lose weight on diets or with appetite-suppressing drugs.

Researchers yesterday presented preliminary data on the usefulness of the approach, which already has been tested on 450 patients to show its safety.

Surgical techniques that shrink the stomach and reroute the digestive tract are the most reliable ways to make obese people lose weight. However, this is major surgery that carries significant risk, including a 1 percent chance of death, and researchers are searching for ways to do the job more safely.

The electrical device is called an implantable gastric stimulator, similar to a cardiac pacemaker. But instead of stimulating the heart, this one is attached to the wall of the stomach and is intended to reduce feelings of hunger.

Researchers implanted the devices in 30 obese women and men whose average weight was 242 pounds. Their average body mass index, or BMI, was 42. The healthy cutoff for the height-to-weight ratio is 25; 30 is considered obese.

After a year with the implant, two-thirds of the volunteers had lost weight. The average was an 18 percent drop in their excess weight.

“The results are promising, although we still have a long way to go,” said Dr. Scott Shikora, head of bariatric surgery at Tufts-New England Medical Center in Boston. “I believe in my heart this is a very exciting breakthrough in our field.”

Dr. Shikora presented the study in Fort Lauderdale at the annual scientific meeting of the American Association for the Study of Obesity. The study was financed by the device’s developer, Transneuronix Inc. of Mount Arlington, N.J.

The system uses an electrical pulse generator, a little larger than a silver dollar, that is placed under the skin in the abdomen and connected to the stomach with two wires. Implanting it takes less than an hour and is an outpatient procedure.

The device is already on the market in Europe but is still several years away from Food and Drug Administration approval in the United States.

Steven Adler, Transneuronix’s executive vice president, said the company hopes in a few months to begin a study on 120 patients that will take two years to complete.

The device is attached near the stomach’s major nerves. Surgeons are unsure exactly why it deadens appetite. Possibilities include an impact on the nerves, changes in digestive hormones or direct stimulation of stomach muscles.

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