Pacemaker-like Device for Weight Loss Makes News
Could a revolutionary new device be the answer for weight loss for many Americans? Here are two news reports that say yes, but with this one caveat to the answer.
ABC News recently reported that the biotech company EnteroMedics may have come up with a new FDA-approved, pacemaker-like weight loss device that could help many Americans finally lose weight.
With an estimated one-third of the country diagnosed as being overweight or obese, researchers are trying to find new options for those who are having difficulty losing weight. One of the latest options that does not require major surgery or sticking to a rigorous diet is the EnteroMedics “Maestro Rechargeable System”―more commonly referred to as “VBLOC”―that consists of an electrical pulse generator and wire leads with electrodes that are implanted surgically around the abdominal vagus nerve.
The mechanism of action of the device is to send intermittent electrical pulses to the abdominal vagus nerve, which is involved in sending messages to the brain indicating whether the stomach is empty or full. Researchers believe that sending electrical pulses to the nerve blocks its normal brain-signaling function, leaving the patient feeling full rather hungry. The result is that the patient with the implant will be better able to control his or her cravings and thus eat less.
In a study consisting of 233 patients diagnosed as obese, all were provided with the VBLOC implant. However, as a control, in 76 of the patients the VBLOC was not activated so that a comparison of results could be made regarding whether electrical pulses were effective in blocking the vagus nerve from signaling the brain that the stomach was empty.
What the study showed was that after 12 months on activated VBLOC, the experimental group lost 8.5 percent more of its excess weight than the control group with approximately half losing at least 20 percent or greater of their excess weight.
According to a statement made by Dr. Scott Shikora, EnteroMedics' Chief Consulting Medical Officer, "VBLOC Therapy offers an entirely new approach to the treatment of obesity. By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss."
However, a WTNH News reports cautions viewers that individual weight loss results achieved from using VBLOC may be much less than those observed in the study:
WTNH News reports that Dr. Nissen Nahmias, a bariatric surgeon at St. Francis Hospital & Medical Center who has implanted patients with the VBLOC during a clinical trial while he was a fellow at a Virginia hospital, stated that his experience is that it’s an alternative designed to help shed 10-percent of the extra weight.
“The results were modest…if you have 100 pounds of excess, the goal would be to lose about 10-15 for every 100 pounds and you would probably lose 8 to 10 pounds,” said Dr. Nahmias pointing out that a gastric bypass would be more effective, but it comes with a higher risk of complications due to it being a significantly more invasive surgical procedure.
“It’s an option for those that are on the fence about a big life-altering operation,” said Dr. Nahmias.
And while the results from the initial study did fall short of expected outcomes by the researchers, the FDA found the procedure safe enough and with enough merit to grant approval for the physicians to provide the VBLOC therapy for obese patients having difficulty losing weight by more conventional and traditional methods.
According to a news release by the FDA, that as part of the approval, EnteroMedics must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions.
FDA press release― “FDA approves first-of-kind device to treat obesity”