FDA Approves Brain-to-Stomach Obesity Treatment to Help Lose Weight At The Source
Struggling with obesity is a difficult life, especially when people feel no one around them understand the problem. Some people blame it on their genes; some people blame it on their lack of physical activity. There’s one way to combat obesity though that even the U.S. government is giving the green light though that could help plenty of people: at the brain.
The United States Food and Drug Administration (FDA) recently approved EnteroMedic’s VBLOC vagal blocking therapy that targets the connection between the stomach and the brain.
“Obesity and its related medical conditions are major public health problems,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist of the FDA’s Center for Devices and Radiological Health. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
A good rule of thumb has been for years to wait 10 minutes before deciding to eat more that you should, due to the delay in feeling full. Messages that you’re done eating start in the stomach and travel to the brain, but it doesn’t register for a few minutes. The VBLOC looks to get rid of that delay altogether.
“This is a novel device that interrupts signals from the stomach to the brain that are believed to be involved with stomach emptying and feelings of fullness,” said Martin Binks, PhD, FTOS, Secretary/Treasurer of The Obesity Society (TOS) and Associate Professor of Nutritional Sciences at Texas Tech University. “In clinical trials, the device resulted in a clinically meaningful weight loss of 8.5% after one year and the FDA determined this was an appropriate risk-benefit profile to approve the device for clinical use.”
The Electrical Obesity Fighting System
The VBLOC, delivered via the Maestro System, consists of a rechargeable electrical pulse generator and well as wire leads and electrodes that are implanted into the abdomen.
It may sound scary to think electrical pulses are telling patients when they’re full. In trials though, patients struggling with obesity, with a BMI of 35 or greater, took the test to see the outcomes. More than 76 of them in the experimental side of the group, opposite the 76 in the control group, lost 20 percent of their excess weight. 38.8 percent more patients in the experimental group lost at least 25 percent.
“We’re encouraged that FDA is willing to continue to consider adding important and innovative new options to the treatment toolbox,” said Binks. “In addition to the five FDA-approved anti-obesity drugs now available, such novel treatment options can give additional choices to individuals with obesity who have found little success with diet and exercise alone. Medical devices can be part of a comprehensive, individualized obesity treatment plan for some patients.”
According to the FDA, the VBLOC is approved to treat patients of at least 18 years old who have struggled with losing weight through a weight loss program. They typically should have a BMI of 35 to 25 and should be sick with at least on other obesity-related condition, such as type 2 diabetes.
“As part of the approval, the manufacturer 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,” the FDA reported, telling patients what’s in store.
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