A new implant that could curb patients' appetites has gotten a step closer to approval by the U.S. Food and Drug Administration (FDA).
The device stimulates stomach nerves to achieve its effects; it would be used in severely obese adults that have not had success in their efforts to lose weight, HealthDay reported.
The FDA's nine-person Gastroenterology and Urology Devices Panel voted eight to one that the Maestro Rechargeable System is safe to use. The committee was not as sure if the device would be effective in patients; four voted "yes" while five voted "no."
"The Maestro Rechargeable System is a safe and effective treatment option for obese individuals who have failed more conservative weight reduction interventions such as diet [and] exercise and pharmacotherapy, but are not able or willing to undergo more aggressive bariatric surgical options," the device company said in FDA briefing papers, HealthDay reported.
The device consists of a "pulse generator" that is surgically implanted under the skin of the chest wall. The high frequency pulses lead along the vagus nerve, which helps control lower abdominal organ function.
The device will be available for patients with a Body Mass Index (BMI) of at least 40; this is considered in the obese range.
The manufacturer EnteroMedics also suggests the device could be used in people with a BMI of at least 30 that have had health problems related to their excess weight and have failed to shed it through diet and exercise changes.
The FDA review looked at a clinical trial in which over 200 morbidly obese patients; out of those study participants 157 received a Maestro implant and 76 received a placebo.
All of the participants went through a standard weight management program in which they received counseling.
Over the next year participants the Maestro implant lost over 24 percent of their excess weight compared with the placebo group that lost only 16 percent. Those with the fake implants also regained about 40 percent of the weight back after the trial ended while those with the implant planned to maintain their weight loss.
