The Food and Drug Administration (FDA) has approved a new implant for controlling appetite, developed by medical research firm EnteroMedics.
The Maestro Rechargeable System developed by the company delivers VBLOC vagal blocking therapy to assist patients dealing with obesity issues that have not been successfully treated using traditional methods. This is the first new medical device for the treatment of obesity to be approved by the FDA since 2007.
"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.
The new treatment is designed for adults with a body mass index (BMI) of 40 to 45 kg/m2, or in the 30-39.9 km/m2 range if accompanied by associated conditions such as high cholesterol or blood pressure.
Maestro is an electronic device, similar to a pacemaker. It is surgically implanted, usually on an outpatient basis, in position to alter nerve signals in the vagus nerve. This structure is vital in regulating digestion. By temporarily blocking the signals that signal hunger, the device can assist people in battles against overeating.
Tests of the device showed subjects using Maestro lost 8.5 percent more weight than participants in a control group. Approval was supposed to depend, in part, on these tests producing results of 10 percent or greater.
"However, an FDA Advisory Committee (the Gastroenterology and Urology Devices Panel) found the 18-month data supportive of sustained weight loss, and agreed that the benefits of the device outweighed the risks for use in patients," FDA officials reported in a press announcement.
The device can be externally controlled by physicians, and the electronic system is recharged by the user. These are significant advances over gastric bands, currently used to reduce stomach volume to reduce overeating.
Side effects of the Maestro delivery system include nausea, vomiting, pain, heartburn, chest pain, and other complications from surgery.
As part of the approval, EnteroMedics will be required to carry out a post-approval study, following 100 or more patients over the course of five years. Insurance companies could take up to two years to approval funding for the process, which could limit adoption of the device in the near future.
Over one-third of adult Americans are obese, leading to higher rates of heart disease, diabetes, stroke, and some cancers.
