For overweight people who have difficulty losing the pounds or keeping them off, there’s a new medical device, pending approval from the U.S. Food and Drug Administration (FDA), that could suppress their appetites and cut down on their between-meal snacks.
The manufacturers of the device, called Abiliti, made by IntraPace of Mountain View, CA, claim that the implant is less invasive and has fewer side effects than stomach stapling or lap-band surgery, reports Bloomberg Businessweek. Instead, the implant is about the size of a half-inch stack of business cards. It sends electrical pulses to the stomach to make people feel full even when they eat less. Also, the device sends signals to the brain to keep people from wanting to eat late at night or between meals.
Patients would undergo laparoscopic to have the device implanted near their stomach. The device uses wireless data tracking that sends information to a social networking support group, with the aim to change eating patterns.
“I am quite interested in the approach, which is a holistic one, instead of just one surgery,” says Otello Stampacchia, managing partner of Omega Funds, which invests in IntraPace, along with Boston Scientific, Johnson & Johnson, and others. “There is an intrinsic element to the approach which I think does lead to behavioral modification.”
The medical device was approved for use in January 2011 in England, France, Spain, Italy, and Germany. Additional safety and efficacy testing required by the FDA means that the device would not be available in the United States for a few more years.
The device helped Katrin Falb, 33, a dietitian in Nuremberg, Germany, lose 51 pounds since she had the device implanted in March 2011. “I work in a hospital kitchen,” says Falb. “If you have food in your sight eight hours a day, you eat a little piece of this, and a piece of that, all day. Nobody controls me. Abiliti is my coach.”
Stomach stapling and lap-band surgery still allow patients to eat between meals if the stomach is empty. Bloomberg adds the following:
Thomas Horbach, a surgeon at Stadtkrankenhaus Schwabach hospital in Germany who serves as the principal independent investigator for Abiliti’s clinical trials, says the device is safer and has fewer side effects than other procedures. Gastric bypass surgery can lead to frequent diarrhea and failure to absorb calcium and iron. Such complications haven’t been observed among Abiliti users, says Horbach, who has no financial ties to IntraPace. He performs about 200 weight-loss surgeries a year.
The battery-powered device can be programmed to set certain periods of the day for meals. At the end of, say, 20 minutes during a mealtime, the device would signal the brain that the stomach is full. If a patient tried to snack between mealtimes, the device would signal the brain that, again, the stomach is full.
The cost of the surgical procedure and the replaceable battery that lasts up to five years is about $19,000 in Europe. Manufacturers expect that the cost in the United States will be more because surgical procedures there cost more.
Long-time efficacy studies on the device are not yet available. However, a 12-month survey of 25 participants that concluded in March 2012 showed that they lost an average of almost 31 pounds.
Dale McGeehon has been a journalist and editor for more than 25 years, covering chemical regulation and testing for Pesticides and Toxic Chemical News and innovations in material sciences for the National Technology Transfer Center. His writing credits include Omni and College Park magazines and The New York Times.