Obesity, a problem that keeps on troubling the globe and the continuous search for better solutions are always on. As a part of this effort, a new obesity device got approval of federal health officials on Wednesday. This device is supposed to control appetite with electrical pulses. Even though it is the first new obesity device in last seven years that got approved by Food and Drug Administration, physicians are yet to figure out the way it works.
The device known as Maestro needs to be implanted surgically. The main purpose of manually controlled Maestro is to interfere with the hunger signals from the brain to the stomach. “The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes,” the FDA said in a statement.
According to NBC’s Diet & Nutrition editor Madelyn Fernstrom, in all probability, this device will be available only in specialized clinics and high chances are there that health insurance will not cover it as of now. The device, once inserted under abdominal skin should interfere with the abdominal branch of the Vagus nerve that controls the heart and digestive tract. To develop Maestro, the company EnteroMedics Inc used a specific technology called VBLOC.
“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,” said Dr. Scott Shikora, chief consulting medical officer for EnteroMedics.
FDA further commented that the specific mechanisms through which this device causes weight loss are still unknown. The device made it to the market through safe trials. The patients lost about 8.5 percent of their excess weight compared to people implanted with a sham device. FDA also said that as part of the approval, there should be a five year post approval study by the manufacturer that will follow at least 100 patients in order to collect additional information related to obesity associated conditions.
According to the agency, serious adverse effects like nausea, pain at the near regulator site, vomiting, pain, heartburn, problems swallowing, belching, mild nausea and chest pain and also surgical complications were reported in the clinical study.