It's being called 'the new way to zap fat.'
But is it the answer to battle of the bulge?
Let's take a closer look at the first weight loss device to be approved by the FDA, since the 2007 approval of the gastric band.
What is it?
The Maestro Rechargeable System is a new FDA-approved implantable device. It sends electric impulses to nerves that communicate between the stomach and the brain, blocking normal signals along those nerves.
The net result is suppression of appetite.
The VBLOC Therapy (Maestro device) is implanted beneath the rib cage and sends electric impulses to the vagus nerve, which goes from the stomach to the brain.
The manufacturer of the device,
EnteroMedics, suggests the impulses should help to specifically limit appetite and suppress feelings of hunger, by blocking regular signals. Patients in clinical trials reported feeling fuller after eating smaller portions.
After the device is implanted, the implant's battery is fueled by an external recharger. Recharging would need to be done every other day for about 90 minutes.
The company anticipates that the battery would need to be surgically changed in 10 years.
What are the costs involved?
The estimated cost without insurance is expected to run between $15,000 and $35,000 for the initial implant of the device. Changing the battery at the 10-year point is estimated to cost between $1000 and $5000.
Which patients are good candidates for the device?
Patients must be at least 18 years old, and have had repeated failures dieting or from failed lifestyle change efforts. They must also have an obesity-related condition like diabetes, heart disease, and a BMI that falls between 35 and 45.
Current estimates suggest that about 20 million adult Americans would fall into that BMI range.
What were the clinical study results?
Researchers aimed to see weight loss results at least 10 percent higher in the group that received the device, versus a control group.
Results from the 12-month clinical study were actually closer to an 8.5 percent higher weight loss, compared to the control group.
EnteroMedics still claims that patient expectations should be a weight loss of 10 percent of body weight within 12 months of receiving the implantable device.
The FDA advisory panel factored in additional data, concluding that the benefits of the device outweighed risks, for certain patient populations.
Is there more research ongoing?
The company must conduct a five-year study to follow at least 100 patients, collecting additional safety and effectiveness data, as part of the FDA approval process.
What were the reported side effects?
Most serious side effects reported by patients included nausea, vomiting, pain, and complications directly related to the surgery.
It should be noted that surgical complications are also associated with the current obesity treatments, gastric bypass and gastric band surgeries.
Will insurance eventually cover this specific weight loss therapy?
EnteroMedics expects to negotiate with insurers over the next year to 18 months, in order to lobby for coverage for the cost of the device and surgery.
Has the device been endorsed by any medical groups or obesity associations?
Obesity Action Coalition
believes that expanded treatment options are necessary to combat the burgeoning rates of obesity.
Adding to the treatment arsenal allows for more therapy options, that may include one or more treatment i.e. diet, exercise, cognitive therapy, medications and surgical treatments.
What are my thoughts?
If you look at the current therapies available, the rate of recidivism in obesity is still quite high.
I'm not sure how this new treatment option will feature into the successful weight loss program of the many patients whose obesity is driven by emotional eating.
These individuals eat without consideration of "hunger or fullness," so it's unclear to me how this device will interact with that reality.
Long-term results of sustained weight loss are also not available, so it's unclear whether the patients who initially lose weight after having the device implanted, will:
- lose more weight
- sustain the weight lost
- have untenable side effects within the five year period
The lack of a five year study right now, also means we don't know what the long-term consequences of this device will be, specifically its impact on the vagus nerve, the brain, and secretion levels of appetite hormones, like ghrelin.
Will the body accommodate to the device, by releasing higher levels of these hormones?
It's also unclear if the weight lost will be regained over time, as is often the case in bariatric and gastric band surgery.
Finally, we don't know if there is a direct benefit for obesity-related diseases like diabetes, which seems to immediately respond to gastric bypass surgery, even when little weight loss occurs.
I also wonder how much lifestyle therapy was used in conjunction with the device during the twelve months post implantation, if any, or if it's recommended as part of the overall therapeutic approach?
The EnteroMedics website does specifically offer that before considering the device, "Individuals should have first tried to lose weight by diet and exercise in a supervised program, within the last five years before receiving the device."