FDA Steps In, Considers New Implant For Severely Obese

June 17, 2014

A new implant designed to curb the appetite by electrically stimulating stomach nerves is under review Tuesday by a key advisory committee of the U.S. Food and Drug Administration.

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 manufacturer, EnteroMedics Inc., said in its application for FDA approval.

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 at Texas Tech University who will testify before the FDA panel on behalf of the Obesity Society.

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“We certainly are encouraged by the FDA’s recent willingness to review treatments for obesity, and we’re hopeful the FDA will give a fair hearing and evaluate the device based on the merits,” Binks said.

The Maestro Rechargeable System, as it’s called, 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., 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 implant’s safety and effectiveness will be evaluated by the gastroenterology and urology devices panel of the FDA’s Medical Devices Advisory Committee.

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.

EnteroMedics said the Maestro also could be used in people with a BMI of at least 35 who have health problems related to their obesity and have failed to lose weight through other programs. (A BMI of 30 is the threshold for obesity.)

FDA Steps In, Considers New Implant For Severely Obese.