THURSDAY, April 7 (HealthDay News) -- Silke Zeigler was fed up
with "yo-yo" dieting in her struggle to maintain a healthy
"The first realization was that diets didn't work and actually made things worse, as after finishing the diet I put the weight I'd lost back on," said Zeigler, 26, a taxi driver from the Wurzburg region of Germany. "So, I researched surgical options such as gastric bypass surgery or gastric banding. But, ironically, for these operations I wasn't overweight enough."
Then the university hospital in Wurzburg offered her a chance to
participate in a trial of an innovative stomach "pacemaker," aimed
at curbing appetite and controlling weight.
Zeigler embraced the idea, in large measure because of the
treatment's reversibility. "That is, it can always be removed again
without permanent effects on the anatomy of my stomach, such as
[happens] in a gastric bypass surgery," Zeigler noted.
Ten months after receiving the implantable device in what she
called a "quite easy" operation, Zeigler said she's lost about 80
pounds and kept it off. "I quickly noticed success because in the
first few weeks I lost 20 kilos [44 pounds] and with every fading
kilo my motivation increased," she said.
The device, not yet approved for use in the United States, is
dubbed "abiliti" by its California-based maker, IntraPace.
According to the company, the device is implanted in the stomach
during a one-hour laparoscopic procedure via small insertions in
the abdominal wall.
Once in place, the device uses its food-detection sensor to
sense whenever a patient eats or drinks. This prompts it to emit
low energy electrical pulses to nerves that trigger a feeling of
According to IntraPace, users can feel "a sensation" from the
tiny impulses the device delivers. Zeigler said that, in her case,
"the feeling of fullness occurs much sooner now than before."
An activity sensor also tracks the patient's food intake and
physical exertion levels, sending that information automatically to
a computer so patients and doctors can easily monitor (and adjust)
eating and exercise habits.
"This is not to police the patients, but to help encourage positive results," explained Chuck Brynelson, IntraPace's chief executive officer.
To date, one completed trial, along with a second one still
underway -- both funded by IntraPace -- have tested the device
among a total of 65 patients. Both studies have been aimed at
assessing the device's safety and effectiveness, rather than
comparing it to other weight-loss methods or medications.
The results of the first study were presented at the 2009
International Federation for the Surgery of Obesity and Metabolic
Disorders meeting. In that trial, study author Thomas Horbach, of
Schwabach, Germany, recruited obese individuals with an initial
pre-implant body-mass index (BMI) of between 35 and 55 (30 being
the statistical threshold for obesity).
After receiving the device, the participants lowered their daily
food intake by an average of 45 percent, the researchers said, and
they lost an average of 22 percent of their excess weight within a
year of implantation.
IntraPace acknowledges that standard gastric bypass surgery
currently produces even more dramatic results -- typically a 50
percent to 60 percent loss of excess weight within a year. Another
type of bariatric surgery, gastric banding, achieves between 34
percent and 38 percent weight loss during the first year
However, the company also points out that the more invasive
bypass and banding surgeries come with more risks: 0.5 and 0.05
percent of such patients die, respectively; while 23 percent to 32
percent of bypass patients and 88 percent to 93 percent of gastric
band recipients experience significant side effects. So far, the
pacemaker surgery has prompted no deaths and no major side effects
in those who have received it, IntraPace said.
But, some U.S. weight-loss experts remain less than enthused
about the device.
Dr. Mitchell Roslin, chief of bariatric surgery at Northern
Westchester Hospital in Mount Kisco, N.Y., said he takes a "very
bearish view" of stomach pacemaker technology, dismissing it as
having the effect of "a glorified placebo."
"The kind of sophisticated communication that goes on between the stomach, the nerves and the brain is not as simple as turning on a light switch," he said. "It's not just about pulsing that nerve on, and hoping that that mimics the way the stomach signals the brain. But, the simple state of obesity pacemaker technology today is that all we can currently do is up the voltage or drop the voltage. And, in my opinion, that's just not good enough."
Another expert, registered dietician and assistant professor of
clinical nutrition Lona Sandon, of the University of Texas
Southwestern Dallas, said it remains to be seen if stomach
pacemakers might have a significant role to play in weight
"Certainly, it could be another tool in the box to help with the obesity problem," she said. "Of course, the studies will have to play out and see what the risks are. But it seems that it is much less invasive and has the potential for less surgical risk compared with bariatric surgery, which is a pretty serious surgery that can entail lots of complications."
There's cost to consider, too: According to Brynelson, abiliti
now costs between $20,000 and $23,000, which includes the device
plus implantation in the stomach. That's based on costs in Britain,
where the device was recently approved for use.
Brynelson said that discussions between Intrapace and the U.S.
Food and Drug Administration are underway, aimed at outlining the
parameters of new trials that would have to be conducted before the
device could be approved for American patients. In the most
optimistic scenario, that would not happen before 2014, he
Sandon stressed that any weight-loss intervention should ideally
include lifestyle changes. "With any of these devices that might
help you eat less, you still need to pay attention to what you put
in your mouth and make healthy food choices and increase physical
activity to promote health overall," she said. "Surgery does not
replace good nutrition. Nor do any kind of implantable devices.
Lifestyle habits are still key for overall health long-term."
Abiliti recipient Zeigler said she couldn't agree more with that
"Of course, [my weight loss] is also due to a change of eating and living habits," she said, noting that since the operation she coupled "a strong desire and will to lose weight" with an avoidance of fast foods and a diet tilted towards salads and whole grains.
For more on standard weight loss surgery options, visit the
U.S. National Institutes of Health.
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