Katrin Falb, a 33-year-old dietitian in Nuremberg, Germany, has struggled with her weight since her early teens. She’s tried everything from Weight Watchers to acupuncture to keep off the pounds. Now Falb may have found the answer to her woes with a device implanted near her stomach.
Made by IntraPace of Mountain View, Calif., the implant, called Abiliti, is the size of a half-inch stack of business cards and sends electrical pulses to the stomach to make people feel full with smaller meals. It also sends signals to the brain to discourage snacking between meals and late at night. Developed with investments from U.S. medical device makers Boston Scientific, Johnson & Johnson, and others, it has helped Falb lose 51 pounds since her surgery 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.”
Patients in England, France, Spain, Italy, and Germany are using the device after it received European regulatory approval in January 2011. IntraPace hopes to soon do the same in the U.S., where one in three adults is obese. The potential market could be huge, since obesity raises risks of diabetes and stroke and costs the U.S. $147 billion a year in medical expenses and lost productivity, according to the U.S. Centers for Disease Control and Prevention. Still, because of additional safety and efficacy testing required by the Food and Drug Administration, U.S. approval may take several more years, says Philip Schauer, a bariatric surgeon at the Cleveland Clinic.
The IntraPace approach, which uses minimally invasive laparoscopic surgery to implant the device and then relies on wireless data tracking and a social networking support group, is seen by some as having a shot at truly changing 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 also invests in IntraPace. “There is an intrinsic element to the approach which I think does lead to behavioral modification.”
Abiliti, which is also backed by venture capital funds including InCube Ventures and Oxford Bioscience Partners, targets those with a body mass index between 35 and 55 (a score exceeding 30 on this body fat measure is considered obese) who are considering stomach stapling or gastric banding procedures, which still allow patients to eat between meals if the stomach is empty. Abiliti is based on technology used in defibrillators and cardiac pacemakers developed by Medtronic, where IntraPace Chief Executive Officer Chuck Brynelsen spent 24 years, most recently as vice president of the cardiac surgery technologies business.
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.
Doctors use the battery-powered device to program the body to allow only a set number of defined windows for mealtimes, say 20 minutes. At the end of an allowed interval, low-level electrical pulses to the stomach send sensations of fullness to the brain. If a patient tries to snack between meals, a food sensor immediately engages the electrode to remind the brain that the stomach is “full.” Explains Horbach: “We try to reprogram the patient’s overall eating behavior.”
Including the surgical procedure and a replaceable battery that lasts up to five years, the total cost of Falb’s implant, covered by government health insurance, was about €15,000 ($19,000). IntraPace declined to estimate a potential price tag for the U.S. market, where bariatric procedures are typically more expensive. Stomach stapling costs about $25,000 in the U.S., according to Cleveland Clinic’s Schauer. Since such more-invasive procedures are covered by U.S. health insurers, Abiliti, if approved, would probably be considered for coverage as well, he says.
A feature of Abiliti is an accelerometer that records when the patient eats, drinks, and exercises. That data can be wirelessly uploaded to a computer, allowing the patient and doctor to monitor progress. Patients can also join a community of Abiliti users through a social networking site called my.abiliti. They may have the device removed at any time if they feel they no longer need it, or they can keep it for life as long as they have surgery to change the battery.
As many as two-thirds of people on diets regain more weight than they lost within five years, according to an analysis of 31 long-term studies on dieting by researchers at the University of California at Los Angeles. Long-term results from studies on Abiliti are not yet available. But a 12-month survey of 25 participants concluded in March showed an average total loss of 14 kilograms (30.9 pounds) and a 30 percent drop in excess weight, or the amount above ideal body weight based on standard height and weight tables.
The results are similar to those from gastric banding surgery, Horbach says. A randomized trial comparing results from 150 patients using Abiliti for a year with those who underwent gastric banding will be released by next June. Horbach says that trial will be an important part of IntraPace’s application to the FDA.