FDA approves EnteroMedics' novel device to treat obesity

Last Updated: 2015-01-14

By Reuters Staff

WASHINGTON (Reuters) - The U.S. Food and Drug Administration has approved a new device to treat obesity, the first since 2007.

Known as the Maestro Rechargeable System, the device, made by EnteroMedics Inc, controls hunger and feelings of fullness by targeting the nerve pathway between the brain and the stomach.

It is implanted surgically into the abdomen and works by sending electrical pulses that interfere with the activity of the vagus nerve, which signals to the brain that the stomach is empty.

A 12-month clinical study showed that patients implanted with the device lost 8.5% more weight than the control group.

That did not meet the main goal of the clinical trial, which was to show weight loss of 10% or more. But an FDA advisory panel considered additional data and concluded that the benefits of the device outweighed the risks for certain patients.

"As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions," the FDA said in a statement.

Serious adverse events reported in the clinical study included nausea, pain at the neuroregulator site, vomiting, as well as surgical complications. Other adverse events included pain, heartburn, problems swallowing, belching, mild nausea and chest pain.