It not only helps get weight off, it helps keep it off, too. (Photo: Getty Images)
This week may mark a changing of the tide in terms of how look at one of the country’s biggest health issues — obesity.
For the first time in eight years, on Wednesday the FDA approved a device to tackle excess weight in patients over age 18 who have tried and failed to effectively diet and exercise: an “appetite pacemaker.”
The Maestro Rechargeable System by EnteroMedics is a device that’s surgically implanted into the abdomen. It uses electrical pulses to stimulate the brain’s vagus nerve, which sends out signals to the rest of the body when the stomach is full or needs to be emptied. Through testing, scientists have figured out that zapping that nerve seems to block those signals exchanged between the brain and the stomach, although they’re not sure why this leads to weight loss.
(Image: Courtesy of EnteroMedics)
Christopher Ochner, Ph.D., an assistant professor of psychiatry and obesity researcher at the Icahn School of Medicine at Mount Sinai, says this new device is very interesting, especially because the mechanism is so unknown. “We’ve looked at what manipulation of this nerve does, and know it affects one of the pathways that regulates hunger, satiety and signaling from brain to stomach,” he tells Yahoo Health. However, although it’s a key player, a lot of the reasoning has not panned out.”
Regardless, it seems like a realistic option that could work for both doctors and patients. Although the Maestro is surgically implanted, outside controllers allow for the patient to charge the device and for the physician to alter its settings. This should help better govern the entire weight loss process with fewer unintended side effects.
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Ochner says that initial data on the device looks good. In a study of 233 patients with a BMI of 35 or higher, 157 were implanted with an active device while 76 were implanted with a deactivated device to serve as the control group. After 12 months, the group with active generators lost 8.5 percent more weight than their control-group counterparts, a significant enough number to account for the inevitable placebo effect.
“The researchers didn’t quite reach their goal of the 10 percent excess weight loss, but this is still very good. It’s a clinically significant difference,” Ochner says. “No one knows for sure if this device will take off, but I expect to see more biologically-based interventions in the future.”
Half of the experimental group lost at least 20 percent of the extra weight they needed to drop, and 38 percent lost at least 25 percent. In addition, after 18 months, the FDA also saw evidence of sustained weight loss, which is a big factor in overcoming the obesity epidemic. The administration agreed the risks were fewer than the potential gains and gave the device its stamp of approval.
But patients should still be mindful of any procedure. “While minimally invasive, the surgery is still surgery and risks exist — just like with bariatric surgery,” says Ochner. “Patients will have to weigh the risks on an individual level and decide which route to choose.”
Who is a good candidate for this device? Only those who have tried and failed to control their weight with healthy diet and exercise — which is the majority of obese patients, says Ochner. In addition, people must be over age 18, be within a BMI range of 35 to 45, and have another comorbid condition like type-2 diabetes or heart disease.
To fully complete the approval process, EnteroMedics will have to conduct an additional five-year study following at least 100 patients using the device to gather final safety and effectiveness numbers on weight loss, side effects, surgical revisions and how the patients’ other, related conditions are impacted. Some side effects reported already are heartburn, chest pain, nausea, swallowing issues, vomiting, and pain at the implant side, so there’s a ways to go in understanding how this “pacemaker” affects the body.
However, the technology is still exciting, says Ochner, especially for those who’ve struggled with their weight and can’t understand why. Currently, there’s little else like the Maestro in the battle a societal epidemic, and it may work because it’s specifically keyed in on the biological battle of obesity.
The condition itself is still a widely misunderstood, and Ochner says the advent of a device of this kind may help us grapple with the misconceptions. “This is meant for obese patients who have tried and failed at controlling their weight with diet and exercise — but let’s face it, that’s most of this group.
There are other internal factors involved in maintaining a healthy weight,” says Ochner. “Overall, this is a good move in the field. Finally, we’re approaching obesity as the biologically-mediated disease that it is.”
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