New FDA-Approved Weight-Loss Device Targets Nerves In The Brain

Jessica Applegate

The United States Food and Drug Administration (FDA) has just approved a new weight-loss device that works with the nerves in the brain, "tricking" it to believe that an individual is full.

According to the Center for Disease Control (CDC), nearly two-thirds of adults in the U.S. are considered to be overweight, and 31 percent fall under the obese category. These are startling statistics when the actual numbers are calculated to be over 79 million people, and by all estimations, that number is only going to increase. With such glaring evidence to the "obesity epidemic" in this country, it is no wonder that such in-depth research has gone into combating the growing obesity population with the use of weight-loss technology such as this.

Obesity, as defined by the CDC, is a label used to measure weight that is greater than what is generally considered healthy for a given height. Height and weight and their relationship to each other is used to formulate a person's body mass index (BMI). This number is used in the medical profession to calculate whether a person is healthy, overweight, or obese. If a person falls within the 25.0 to 29.9 range, they are considered to be overweight, and those falling within the 30 or higher range are considered to be obese. For individuals who are within the latter range, the number of health risks dramatically increase. For obese individuals, the likelihood of developing conditions such as coronary heart disease, type-2 diabetes, cancer, and sleep disorders such as apnea is nearly a certain outcome.

The device, called the Maestro Rechargeable System, is the first FDA-approved weight-loss device since 2007, and is developed by the Entero-Medics Corporation. The company's website describes the device as a "non-anatomy altering or restricting, reversible therapy that allows patients to safely lose weight by helping patients feel less hungry, reduce the amount of food eaten at a meal, and feel full longer in between meals."

The gadget itself isn't large, and is similar in appearance to that of an insulin pump used by many diabetes sufferers. However, unlike the pump, elements of the device are implanted deep inside a patient's body in order to work, rather than just under the surface of the skin.

Wire leads and electrodes are surgically implanted into a patient's stomach, and are connected to an external rechargeable electrical pulse generator. The generator sends intermittent electrical pulses to the abdominal vagus nerve, which is responsible for sending signals to the brain regarding feelings of hunger, fullness, or emptiness. These pulses interrupt those feelings of hunger and trick the brain into believing the stomach is full, which prompts the patient to stop eating. The pulses continue after a meal and convince the brain that the stomach is fuller longer than it actually is.

The complete analysis as to just how this process works is still under research, but studies conducted by the FDA have shown promising results so far. In a clinical trial including 233 patients with a BMI of 35 or greater, the device appeared to significantly increase the amount of weight participants were able to lose versus those in the control group. A total of 157 patients had an activated device implanted, and 76 were given a non-activated device. After 12 months, results showed that those with an activated device lost a total of 8.5 percent more weight than those with a non-activated one. Over half of the experimental group lost 20 percent of their body weight, and 38 percent lost 25 percent of their body weight.

As with all medical devices, there are risks and side effects associated with it. Some patient's reported moderate to high feelings of nausea, pain at the site of internal electrodes, and vomiting. Other side effects included pain, heartburn, problems swallowing, and chest pain.

The device isn't currently approved for use by everyone. It is only being used for patients aged 18 and older who have not successfully lost weight with a traditional weight-loss program, and who have a BMI between 35 to 45. The patient must also have at least one obesity-related condition such as diabetes or heart disease in order to qualify for the device's use.

While some would argue that medical advances such as these don't tackle the causes of obesity themselves to prevent the ever-increasing number of individuals with the condition, others are looking to the life-saving properties that gadgets like this one can offer.

William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, weighed in on the issue.

"Obesity and its related medical conditions are major public health problems. Medical devices can help physicians and patients to develop comprehensive obesity treatment plans."

With weight and obesity being a near obsession in the United States and elsewhere, a new medical device approved for weight-loss is a beacon of hope for some. Many weight-loss pills and supplements are available but aren't yet known to be completely effective.

Would you be willing to accept the known health-risks associated with a weight-loss device such as this one, or would you rather rely on traditional means of losing weight?

[Image courtesy of Venture Beat]