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Gastric Pacemaker

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Bulimia can easily both rule and ruin every respect of the binge eating disorder bulimics life!

Bulimia is an eating disorder defined by routinely binging on large amounts of food, then purging all that food.

A typical food binge would be say, 10 or more donuts, a box of spaghetti, a pound of swiss cheese and a package of potato chips.

Seemingly little will quiet the bingers food urges until a researcher found a new new use for an old medical device.

A pacemaker which works and is similar to a cardiac heart pacemaker.

The anti-bulimia "bulimia pacemaker" is implanted under the patient's arm. Then on a 24X7 five-minute schedule it sends

short electrical shocks which medical and diet researchers believe re-regulates important nerves which connect the brain

and stomach.

Of the medical trial patients who have had the bulimiapacemaker implanted, they all showed improvement in their bulimia condition.

But not all doctors and physicians are convinced as a larger medical trial is needed for more convincing evidence - pro or con.

Researchers admit the medical tests are early and small but they say the results thus far are not only hype but quite

encouraging so far.

Pacemakers used on bulimic patients are the first ray of hope bulimia illness can be controlled.

Since the bulimia treatment pacemaker was installed in her body the female patient recently reported no bulimic episodes

in several weeks. The only noticeable sign she's being treated for her bulimia by a medical pacemaker is that when the

electrical shock is discharged from the pacemaker it causes a small pinch in the throat and causes her voice to vibrate

slightly or change pitch a bit.

Perhaps the the most amazing revelation of pacemaker use for bulimia is the apparent fact the small pacemaker device

works so well at reducing bulimia symptoms. It seems to be proof, researchers say, that bulimia is not only a mental problem

but is a real physical disorder.

Curing bulimia medically and not blaming on on a weak mind which is out of control removes the shame and embarrassment

the bulimia patient was responsible for bulimia and not something he necessarily brought on himself or herself. The bulimia

pacemaker is something which can show bulimia is not only a physiological disorder!

Thus far bulimia may not be totally cured in medical testing patients but they are "better." If this small disk holds up to the

rigors or more testing and medical research, some predict bulimia patients could be on the road to a full eating disorder

recovery!

Background

Researchers at the University of Pennsylvania and eight other medical centers plan to implant the device in about 200

volunteers in a two-year trial.

Transneuronix Inc. of Mount Arlington, N.J., which has developed the gastric pacemaker, hopes the results from the trial

will lead to marketing approval from the Food and Drug Administration.

"It is an exciting new development in the surgical field and less invasive," said Gary Foster, the clinical director of Penn's

Weight and Eating Disorders Program and the principal investigator for the study's Philadelphia site.

Currently, weight-loss surgery involves shrinking the size of the stomach to limit the amount of food that can be eaten. It is

considered the only effective way for morbidly obese people to lose weight, long term; about 141,000 people are expected to

have the surgery this year.

But these surgical procedures have risks, infection, blood clots, ulcers and even death. They are also costly,

approximately $25,000. Scott Shikora, chief of bariatric surgery at Tufts-New England Medical Center who has studied the device

for a number of years, said he doesn't believe it will replace the current surgical weight-loss techniques. Because it

appears to have a good safety profile, it may be well-suited for patients who aren't candidates for bariatric surgery.

How the Gastric Pacemaker Works

The experimental device - which is called an implantable gastric stimulator - is a small battery-operated electrical

generator about thesize of pocket watch that is surgically implanted in the abdomen. 2 wires

connect it to the stomach wall.

In a similar way that a pacemaker sends electrical impulses to the heart, the experimental gastric pacemaker

gives a small current to the stomach through 4 electrodes on the wires. The electrical current is activated, adjusted

or monitored by a handheld computer in the doctor's office that communicates to the pacemaker

through a radio signal. (Patients typically don't feel anything during gastric stimulation, according to the company.)

It is unclear how the electrical current works. It might cause the stomach to relax and signal a feeling of fullness.

It could inhibit stomach hormones that normally increase appetite. Or it may send a satiety message to the brain.

Weight Loss Results so far

About 500 people have received the experimental gastric pacemaker in the United States and Europe since it was

first developed in the mid-1990s. Candy Bradshaw, a 47-year-old Worcester, Mass., corporate manager, had the

device implanted in 1999 as part of an earlier study. She said she has lost about 100 pounds using it,

going from a size 28 to a 14. "You don't feel the device at all," said Bradshaw, who'd still like to lose an

additional 30 or 40 pounds. She said the gastric pacemaker makes her feel full more quickly when she eats,

so she isn't tempted to go back for second or third helpings. And one bite too many, she said, will leave

her feeling "Thanksgiving full."  The device has helped her take a hard look at her food choices and her

lifestyle, Bradshaw said. She now power-walks five to seven miles a day and watches the

amount of food she eats.

"You have to work with this device," she said. "It has helped me lose weight... . It is not a magic pill."

So far, study results have been mixed.

"After the implantation of more than 200 patients globally, it was found that some patients responded

strongly and lost significant weight, while others seemed to have little or no response...," Shikora

wrote this year in the journal Obesity Surgery. In the journal, he said some patients didn't fare well in

the early trials because the wires dislodged, people had abnormal eatingbe havior, or the current was

too low. Transneuronix also discovered that some people seem to be predisposed to doing well with

the device and has developed a screening procedure to weed out those who won't.

Weight Loss Implications for the future

"Researchers don't believe there is one cause of obesity," he said. ".... there is not going to be one

treatment that will work for every patient. Our screen is very much focused on identifying patients

who respond to our therapy."

The device gained marketing approval last year in Europe, he said, but the company plans to delay

its sales push until after the U.S. trial is complete next year. In June, surgeons implanted a

pacemaker in a 16-year-old patient with gastroparesis, a debilitating stomach condition that affects

the way the body processes food. This is the first time the procedure has been performed in a child

at Nationwide Children’s Hospital, which is now one of only a handful of institutions across the

country offering this type of treatment in children. Gastroparesis is a condition where the

stomach contracts less often and less powerfully, causing food and liquids to stay in the

stomach for a long time. In as many as 60 percent of children with gastroparesis, the cause

is not known. The condition often leaves children feeling constantly bloated and nauseated

and can result in malnourishment and significant weight loss. In severe cases, symptoms

may prevent children from attending school or taking part in other daily activities.

The pacemaker is inserted into the abdomen, with electrical wires leading to the stomach.

It sends electrical impulses to stimulate the stomach after eating.

"The pacemaker is surgically implanted under the skin and is connected to two

electrodes placed on the stomach wall. It tells the stomach

to empty at a certain frequency. The initial settings are fairly low and, as with a pacemaker

in the heart, we can change the settings as needed,” explained pediatric surgeon Steven

Teich, MD, surgical director of the Bariatric Surgery Program at Nationwide Children’s Hospital

and clinical assistant professor of surgery at The Ohio State University College of Medicine. “It

empties the stomach, alleviating bloating,

vomiting and nausea.”

Gastroenterology, Hepatology and Nutrition at Nationwide Children's Hospital is one of

the leading programs in the country in the field of diagnosing and treating gastrointestinal

motility problems in children. It is the only children’s hospital in the nation that offers the full spectrum

of treatment options for motility disorders, including diagnosis, medications, endoscopic procedures,

surgical options, pacemakers and follow up care.

Pacemakers have been used for years in adults with delayed gastric emptying. Nationwide

Children’s received IRB approval to implant the device in children as a humanitarian device

exemption (HDE), and although this is a new procedure in children and adolescents, doctors at

Nationwide Children’s say the early results are promising.

“In patients who have received this type of treatment, nearly all symptoms were resolved

within two weeks,” said pediatric gastroenterologist Hayat Mousa, MD, medical director

of the Motility Center at Nationwide Children’s Hospital and associate professor of Clinical Pediatrics at The

Ohio State University College of Medicine. “Previous treatment options, including medications, have been

much less effective.”

Percutaneously placed electrical gastrointestinal pacemaker stimulatory system, sensing system,
and pH monitoring system, with optional delivery port
The present invention provides a system for delivering electrical impulses of suitable magnitude and
frequency to the inner lining of the gastrointestinal tract. The system senses the motor activity of
the intestinal tract, thus providing feedback as to the body's response to the imposed electrical
stimulation. Further, the system monitors critical parameters of gastrointestinal luminal contents,
such as pH. Moreover, the system may include a delivery port for administration of fluids or materials
to the gastrointestinal tract, and/or for removing fluids or materials from the gastrointestinal tract.
Preferably, the system penetrates the skin surface and the inner lining of the gastrointestinal tract,
in the stomach, intestine, or colon. The invention provides embodiments which can be adapted for
easy removal for placement on a short-term basis, as well as embodiments having a longer-lasting
design for placement on a relatively permanent basis.