FDA Panel Backs Appetite-Curbing Implant for Severely Obese
Agency committee says nerve-stimulating device may offer more benefits than risks
By Dennis Thompson
TUESDAY, June 17, 2014 (HealthDay News) -- A new implant designed to curb the appetite by electrically stimulating stomach nerves may have moved closer to U.S. Food and Drug Administration approval on Tuesday.
The device is aimed at severely obese adults who have failed to slim down using traditional methods, but don't want, or can't have, weight-loss surgery, the device's manufacturer, EnteroMedics Inc., said in its application for FDA approval.
The FDA's nine-person Gastroenterology and Urology Devices Panel -- a key advisory committee -- voted 8 to 1 that the Maestro Rechargeable System is safe when used as designed, and 6 to 2 (with one abstention) that the device's benefits outweighed its risks.
The panel was less decisive on a third vote, on whether the device would be effective for patients: On that vote, 4 panelists voted yes while 5 voted no.
The FDA is not obligated to follow the decisions of its advisory committees, but it usually does.
In the United States, more than one-third of adults are obese, according to the U.S. Centers for Disease Control and Prevention. This increases their risk of serious health issues such as heart disease, diabetes, depression and cancer, experts say.
Despite this, "we have very few tools at our disposal compared with other chronic diseases," said Martin Binks, an associate professor of nutritional sciences at Texas Tech University who was scheduled to testify before the FDA panel on behalf of the Obesity Society.
"We certainly are encouraged by the FDA's recent willingness to review treatments for obesity," Binks said.
The Maestro Rechargeable System sends electrical signals to nerves around the stomach that help control digestion. These signals block the nerves, decreasing hunger pangs and making the person feel full, the St. Paul, Minn.-based manufacturer said.
In clinical trials, obese people with a Maestro implant lost an average 8.5 percent more weight than others who received a fake implant, the device maker said.
"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/exercise and pharmacotherapy, but are not able or willing to undergo more aggressive bariatric surgical options," the device company said in FDA briefing papers.
The Maestro consists of a "pulse generator" surgically implanted under the skin of the chest wall. This delivers high-frequency electrical pulses to leads laid along two trunks of the vagus nerve, which helps control the function of many organs in the abdomen.
The device is intended in use for people with a body mass index (BMI) of at least 40, which is extremely obese. BMI is a measurement of body fat based on height and weight.