However, in January 2015, the US Food and Drug Administration (FDA) approved the Maestro Rechargeable System that is being touted as a possible health solution for certain obese adults.
The FDA reports that according to the Centers for Disease Control and Prevention, “…people with obesity are at increased risk of heart disease, stroke, Type 2 Diabetes and certain kinds of cancer.” (3)
Could this device truly become the best defense for those suffering this 21st century disease?
This latest weight loss treatment device is said to be the first of its kind and “targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness”.
The device literally shuts off the switch, something that is set to the “on” position most of the time for those suffering from Type 2 Diabetes, the most common cause of obesity (4).
Eligibility to Use Device
The Maestro Rechargeable System is approved to treat anyone 18 years or older. To meet the eligibility criteria the person must have a body mass index (BMI) between 35 and 45 and unable to lose weight with a weight loss program. In addition, the person must also have at least one other obesity-related condition, such as Type 2 Diabetes.
Using individual weight and height, the National Heart Lung and Blood Institute (NHLB) (5) is able to determine the person’s body fat. There are four categories that include:
–> Underweight = <18.5 --> Normal weight = 18.5–24.9
–> Overweight = 25–29.9
–> Obesity = BMI of 30 or greater
There are two limitations with the system used for calculating the BMI. For example, an athlete or someone with a muscular build could incorrectly be assessed as overweight or obese, since muscle weight would be calculated as fat.
An older person or someone who suffers from lost muscle weight may be incorrectly calculated and their BMI underestimated.
How New Device Works to Help Obese Patients Lose Weight
The Maestro Rechargeable System (manufactured by EnteroMedics of St. Paul, Minnesota) is a “rechargeable electrical pulse generator, wire leads and electrodes”. Abominable surgery is required to implant the electrodes, but it’s considered non-evasive since the device is placed underneath the skin.
The device has an eight-year lifespan. There are external controllers that the patient uses to charge the device. Health care professionals can adjust the settings as needed through the external control. As a word of caution, the FDA states, “the specific mechanisms for weight loss due to use of the device are unknown”.
Once in place, the electrodes send intermittent pulses to the base of the abdominal vagus nerve. This nerve signals the brain when you’re hungry and when you aren’t.
The vagus nerve is “the longest cranial nerve”. (6) The nerve contains “motor and sensory fibers”.
The right and left nerve travel from the brain to form the “posterior vagal trunk” along the lower esophagus and then enters the diaphragm (7). From there it travels to the abdomen.
Aside from communicating with the brain when the stomach is full or empty, it also regulates the emptying of the stomach. By sending electrical pulses along this nerve, the communication can be disrupted so that the brain evaluates the stomach is full. Without that signal, the individual doesn’t experience hunger.
With Type 2 Diabetes, the most common cause for overweight, patients suffer from constant hunger, even after they’ve eaten a full meal. Insulin resistance prevents glucose from entering muscle tissues. In turn, a message is sent to the brain that the body needs more energy. This lack of communication causes overeating (8).
Clinical Trial Results
The clinical trial for testing the Maestro Rechargeable system consisted of 233 patients. These patients had a BMI of 35 or greater. Out of this group, 76 patients were used as the control group with non-activated devices. The devices of the remaining 157 patients (experimental group) were activated.
After a period of 12 months, the 157 patients in the experimental group compared to the control group had 8.5% more loss of excess weight. 52.5% of the experimental group lost 20% excess weight, while 38.3% lost 25% excess weight.
The original goal was for the experimental group to realize at least 10% more excess weight loss than the control group. The FDA Advisory Committee found that the 18-month data supported sustained weight loss and agreed that the device benefits outweighed patient risk of those eligible for the device implant.
Part of this approval includes the mandate that the manufacturer conducts a 5-year post approval study. This study must follow a minimum of 100 patients to “collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions”.
Side Effects of Implant Device for Obesity
There were some reported side effects of the implant device during the clinical trials (9). These included:
–> Pain at the neuroregulator site
–> Surgical complications
Other adverse events included:
–> Chest pain
–> Mild nausea
–> Problems swallowing
William Maisel, M.D., M.P.H., chief scientist and the deputy director for science in the FDA’s Center for Devices and Radiological Health explains that, “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
If the Maestro Rechargeable System continues to be successful in treating obesity, it may become a normal component of a medical treatment plan.
References & Image Credits:
(2) TSW: Is the Obesity Epidemic a Weight Loss Industry Fraud?
(7) Wikipedia: Vagus Nerve
(8) Endocrine Web
(10) palomaleca via Compfight cc
(12) CBS News
(13) wader via Compfight cc