Katrin Falb, 33, a dietitian with a weight problem since her early teens, has tried everything from Weight Watchers to acupuncture. Now Falb may have found the answer to her woes with a device implanted near her stomach.
The product, made by IntraPace Inc. and 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.
The implant, developed with investments from medical device makers Boston Scientific Corp. of Natick and Johnson & Johnson and others, has so far helped Falb lose 51 pounds since her surgery in March 2011.
Patients in England, France, Spain, Italy ,and Germany are using the device after it received European approval in January 2011, and California-based IntraPace is preparing to seek approval in the US, where one in three adults are obese. Obesity raises risks of diabetes and stroke, and costs the US $147 billion a year in medical expenses and lost productivity, according to the US Centers for Disease Control and Prevention.
IntraPace isn’t the first company to develop a hunger-controlling device, but those earlier attempts have yet to prove they’re any more effective than diet and exercise. The IntraPace approach, which includes data tracking and a social networking support feature, is seen as having a better shot at truly changing eating patterns.
“I am quite interested in the approach, which is a holistic one, instead of just one surgery,” said 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.”
Still, because of additional safety and efficacy testing required by the Food and Drug Administration, US approval may take an extra three to five years after European clearance, said Philip Schauer, a bariatric surgeon at the Cleveland Clinic.
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 who are considering stomach stapling or gastric banding procedures, which still allow patients to eat between meals if the stomach is empty. Body mass index is a measure of body fat calculated using a person’s height and weight. People with a reading of 30 or more are considered obese, according to the US Centers for Disease Control and Prevention.
The device is based on technology used in defibrillators and cardiac pacemakers developed by Medtronic Inc., where IntraPace chief executive Chuck Brynelsen spent 24 years, most recently as vice president of the cardiac surgery technologies business.
Abiliti, which is implanted through minimally invasive laparascopic surgery, is safer, with none of the typical side effects that accompany other bariatric procedures, Thomas Horbach, a bariatric surgeon, said in an interview at the Stadtkrankenhaus Schwabach hospital in Germany. Gastric bypass surgery can lead to frequent diarrhea and failure to absorb calcium and iron, which has not been observed among Abiliti users, according to Horbach.
Horbach serves as the principal independent investigator for Abiliti’s clinical trials and he personally performs about 200 weight-loss surgeries a year. He has no financial ties to the company.
Doctors use the battery-powered device to program 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 is snacking between meals, a food sensor picks up this “disallowed” activity and immediately engages the electrode.
“We try to reprogram the patient’s overall eating behavior,” Horbach said.
Including the surgical procedure and a replaceable battery that lasts as long as five years, the total cost of Falb’s implant, covered by health insurance, was about $19,000.
The company declined to provide a potential price tag for the US market, where bariatric procedures are typically more expensive. Stomach stapling costs about $25,000 in the US, according to Schauer. As those procedures are covered by health insurers, Abiliti, if approved, would probably be considered for coverage as well, he said.
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.
IntraPace’s method may help dieters overcome the odds of weight loss. As many as two-thirds of people on diets regain more weight than they lost within four or five years, according to an analysis of 31 long-term studies on dieting by researchers at the University of California, Los Angeles. That may be because dieting results in changes in levels of hormones such as ghrelin, which stimulates hunger, and facilitates weight regain, University of Melbourne researchers said in a study published in the New England Journal of Medicine in October.
Long-term results from studies on Abiliti are not yet available. So far, a 12-month study concluded in March of 25 participants showed an average total loss of 14 kilograms and a 30 percent drop in excess weight, or the amount above ideal body weight.
The results are similar to those from gastric banding, which involves wrapping a silicone band around the stomach to limit food intake, Horbach said.
The study also found through interviews that patients’ feelings of loss of control over eating and levels of hunger were reduced after three months, a state sustained through the full year.
Patients may have the device removed at any time if they feel they don’t need it any more, or they can keep it for life by changing the battery every five years or so.
A randomized trial comparing results from 150 patients using Abiliti for about a year with those who underwent gastric banding surgery will be released by June, Brynelsen said. That trial will be an important part of the application to the FDA, Horbach said.
Competing devices have been developed by companies such as EnteroMedics Inc., based in St. Paul, Minn. Abiliti may have an edge in part because of its data reporting features, said Maria Collazo-Clavell, an endocrinologist at Mayo Clinic in Rochester, Minn., who isn’t involved in IntraPace’s research.
EnteroMedics said in April a study of its VBLOC device, which is approved in Europe and Australia, showed an average 22.5 percent excess weight loss over 30 months for 19 patients. It is currently conducting a larger trial needed for FDA approval with 233 patients comparing against a placebo and will announce results in the first quarter of next year, said Jody Dahlman, manager of investor relations.
“There’ve been a lot of electric stimulation devices that have failed to show any advantage over placebo” or other weight-loss surgeries, Cleveland Clinic’s Schauer said. Still, “we do need something that is more effective than dieting and exercise and safer than surgical operations.”
For Falb, Abiliti has far surpassed her other efforts to slim down, and she has set a goal of losing another 5 kilograms before considering taking out the device.
“Weight loss is not the biggest problem,” she said. “The hardest part is when you lose 20 kilograms and you now weigh 80 kilograms, is to still be at 80 kilograms for the next two, three, four years.”