Almost 40 million U.S. adults are obese, according to the Centers for Disease Control, and this year some 70,000 of them will go under the knife to have their stomachs bypassed or stapled in painful and expensive procedures that prevent overeating. But if human trials now under way in the United States pan out, overweight people may one day have a less invasive surgical option: a device that helps people feel full by stimulating the stomach with electricity in much the same way a pacemaker stimulates the heart.The device, under development by Transneuronix of Mount Arlington, NJ, consists of a long flexible wire attached to a pocket-watch-size metal case that contains a battery and an electronic controller, says Steve Adler, Transneuronix vice president. In a brief procedure that could be performed on an outpatient basis, doctors laparoscopically implant the electrode-bearing wire into the muscle around the stomach and insert the case under the patient’s abdominal skin. When the device is activated two weeks later, it begins to deliver high-frequency electrical pulses to the patient’s stomach.
In studies in Europe, where the device was recently approved for use, patients consistently achieved “reasonably good weight loss” after implantation, says surgeon Scott Shikora, associate director of the Obesity Consult Center at New England Medical Center in Boston. Shikora, who is the lead researcher in the device’s U.S. clinical trials, believes it is safer than conventional surgical procedures, all of which “have the potential for very serious complications,” he says.
By itself, however, the device may not be powerful enough to overcome Americans’ supersized appetites. In the first human study in the United States, some patients actually gained weight after the procedure, Shikora says, adding that volunteers in the experiment had received no dietary instructions or behavioral screening with their surgeries. Transneuronix is now conducting more trials to see whether the device, combined with dietary guidelines and support groups, can help obese patients shed extra pounds. If all the research goes according to plan, Adler says, the device could be on the U.S. market within three years.