New pacemaker-like for the stomach looks to tackle obesity.
New pacemaker-like for the stomach looks to tackle obesity. - 
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Obesity and related complications cost Americans roughly $150 billion per year in health care spending. And there’s still no silver bullet for treating obesity. Diet, exercise and surgery all work to a point, but these methods are plagued by relapses. It’s hard for most obese people to lose weight and keep it off.

But a new device approved by the FDA last year will attack obesity in a novel way. VBLOC therapy, which is delivered by the “Maestro system,” is essentially a pacemaker for the stomach. It is implanted under the skin, and ledes connect to the vagus nerve.

Mark Knudson, founder and president of Enteromedics, developed the technique. He said he realized that controlling hunger could be an integral part of obesity treatment.

“We tried to develop a way to treat a disease that affects millions of people in the U.S. without having to alter their anatomy or make them have to completely change everything that they eat,” he explained.

For some people, he said, combatting their obesity is a constant struggle – even at the grocery store.

“Can I go into a store and just buy the five items I want, or am I going to end up filling up my grocery cart and taking it all home?” he asked.

VBLOC sends signals to the stomach branch of the vagus nerve during waking hours. The electrical pulses interrupt the complex neurological process of hunger and, in essence, allow people who are obese to feel full. That makes it easier to decide not to eat.

Erica Roy-Nyline struggled with obesity for years. The 48-year-old health care worker from St. Paul, Minn., signed up for a trial of the treatment because diet and other weight loss methods hadn’t worked.

For the first year after she had the device implanted, she lost about five pounds.

“The one thing I said to myself is: ‘I will not go backwards. I will not gain weight on this thing,’” she said.

But after a year, researchers told her that she was in the placebo group – her device hadn’t actually been turned on. After it was turned on, she quickly dropped 30 pounds – half of her total weight loss goal.

“It’s just night and day,” Roy-Nyline said. “I couldn’t believe that sense of fullness and sense of satisfaction when I was done eating. I thought through… I don’t think I’ve ever really had that feeling.”

Her weight loss has been so dramatic that she’s thinking of going off her blood pressure medication. That’s because losing even a small amount of weight helps to improve obesity comorbidities, or related health complications.

If all this sounds like the silver bullet in the treatment of obesity, there’s a catch: the cost. The device’s cost isn’t officially set yet, but Enteromedics says it will be approximately $15,000 – and that does not include the costs of surgery and followup.

Melissa Martinson, president of the health economics consulting firm Technomics Research, says insurance companies might not rush to cover the treatment, even if it is highly effective.

“A lot of times insurance companies will claim they don’t consider cost when they make coverage decisions,” she said. “But most health economists and most people who work in the field don’t think that’s literally true.”

Aside from cost, insurers will consider safety and efficacy before approving something like VBLOC for people who are obese. Martinson says that defibrillating pacemakers, which are now common, faced similar hurdles when they were released.

And as for efficacy, that may be the toughest hurdle. William Dietz, director of the Redstone Center at George Washington University’s Milken Institute of Public Health, says obesity treatments have always struggled when it comes to maintaining weight loss. It’s still unknown if VBLOC’s effects will sustain over time or whether they will diminish.

“People are losing weight all the time, they just can’t sustain that weight loss,” Dietz said. “So we know the types of therapy available need to be long term.”

But the benefit of even a slight reduction in obesity has impacts on health. A five to 10 percent loss of excess weight can start to reverse high blood pressure, diabetes and other comorbidities.

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Follow Tim Fitzsimons at @@tfitzsimons