The United States Food and Drug Administration (FDA) has approved a new implant or pacemaker for controlling appetite on Wednesday. The device can zap appetite making hunger less noticeable by users. The device was developed by a medical research firm, EnteroMedics.
The device, called Maestro Rechargeable System, utilizes the VBLOC vagal blocking therapy to aid patients in battling obesity. It uses electrodes that are implanted in the abdomen of the patient. It can control the vagus nerve. This nerve is in charge of signaling the brain if the stomach is empty or full. Hence, it can stop the brain from signaling that the patient needs to eat. An external controller can be adjusted by the doctor or the patient.
It is the first medical device that was approved for obesity since 2007 when FDA approved a gastric bond from the company, Ethicon. The device is only recommended for patients who are 18 years old and above, has a body mass index of 35 to 40 and has an obesity-related health condition like diabetes type 2. Body mass index which calculates the body fat based on an individual’s weight and height, is a measure to categorize the person into many obese categories.
The procedure is fast and minimally-invasive. The device is also battery-operated that can be charged weekly.
“Obesity and its related medical conditions are major public health problems. Medical devices can help physicians and patients to develop comprehensive obesity treatment plans,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health.
“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,” Scott Shikora, chief consulting medical officer for EnteroMedics said.
According to a press release by FDA, The device has undergone a clinical trial involving 233 patients who are obese. The effects were compared between 157 patients in the experimental group and 76 patients in the control group. After 12 months, the experimental group lost 8.5 percent more of their excess weight than the control group. FDA considered the result of the clinical trial as well as the panel’s recommendations in approving this breakthrough device.