Michael McKenna West Hartford - Severely Obese Now Have FDA Backed Implant
Michael McKenna West Hartford - EnteroMedics Inc. has created a new electrical stimulant implant to help severely obese adults lose weight. They sent their application in for U.S. Food and Drug Administration approval. An FDA panel has given their approval to back the device, which takes the implant to the next level for overall approval from the FDA. The panel that reviewed the device was made up of nine Gastroenterology and Urology professionals that work for the FDA as an advisory committee. They voted 8 to 1 that the device is safe, 6 to 2 (with an abstention) that the devices benefits outweighed the risks and 4 to 5 that the device will actually be effective for patients. While the committee’s votes and recommendations do not really have any official bearing on whether the device will be approved, the FDA usually goes with committee’s recommendations. This device will help severly obese adults that have tried diet and exercise, but are not willing to take a more drastic option like surgery. The Maestro Rechargeable System works with an implant just under the skin that sends electrical signals to the nerves around the stomach that control digestion. The idea is that the electrical signal will block the nerves that put out hunger pangs. Without these hunger pangs the patient will feel full and therefore not want to eat as often. In the U.S. over a third of adults are obese, according to the Centers for Disease Control and Prevention. When you are obese you are more likely to have health issues like diabetes, heart disease, depression, and cancer. Martin Binks, a professor of nutritional sciences as Texas Tech University and FDA consultant says that despite the high rate of obesity in this country and the many health risks, “we have very few tools at our disposal compared with other chronic diseases. We certainly are encouraged by the FDA’s recent willingness to review treatments for obesity.”
