The US Food and Drug Administration (FDA) has approved the partial use of an implant that proposes to treat obesity by curbing appetite. The first-of-its-kind implant will do so by electrically stimulating the stomach nerves. The FDA said that the device, when tested on an experimental group, helped obese people get rid of 24% of their excess weight or 9% of their total body weight within a year with the help of this implant.
The device which will now be available for some use on some obese people in the U.S. consists of a rechargeable electrical pulse generator, wire leads and electrodes are implanted surgically into the abdomen, writes NPR. It works by sending intermittent electrical pulses to the vagus nerve, which is the pathway between the brain and the stomach and transmits feelings of hunger and fullness to the brain.
The FDA has approved the use of The Maestro Rechargeable System developed by the American company EnteroMedics on patients aged 18 and above who have not been able to lose weight with a weight loss programme, and who have a body mass index of 35 to 45 with at least one other obesity-linked condition, like type-2 diabetes.
According to the Centres for Disease Control and Prevention (CDC), more than 30% of all US adults are obese, placing them at an increased risk of heart disease, stroke, type-2 diabetes and certain kinds of cancer.
“Medical devices can help physicians and patients develop comprehensive obesity treatment plans,” said William Maisel, deputy director for science and chief scientist at FDA’s Centre for Devices and Radiological Health.
The safety and effectiveness of the system were evaluated in a clinical trial that included 233 patients with a BMI of 35 or greater. A few participants complained of abdominal pain and heartburn. To make sure that no harmful side-effects result from the usage of this unique device, the FDA has ordered EnteroMedics to follow at least 100 additional patients over the next five years.
The results of the clinical study are published in the journal of the American Medical Association JAMA.