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 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 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.
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.
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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.
The FDA is not obligated to follow the decisions of its advisory committees, but it usually does. Centers for Disease Control and Prevention. This increases their risk of serious health issues such as heart disease, diabetes, depression and cancer, experts say.
The device is aimed at severely obese adults who Air Max 90 Grey And White 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.
"We certainly are encouraged by the FDA's recent willingness to review treatments for obesity," Binks said.
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 Nike Air Max Black Leopard
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on behalf of the Obesity Society.
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 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.
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