The Maestro Rechargeable System

Neural network, artwork
Neural network (artwork). Science Photo Library - KTSDESIGN/Getty Images

On January 14, 2015, the U.S. Food and Drug Administration (FDA) approved the first-of-its-kind medical device for the treatment of obesity. This device, known as the Maestro Rechargeable System, has been approved for use in certain adults who are obese. This is the first medical device to be approved by the FDA for the treatment of obesity since 2007.

Given that, according to the Centers for Disease Control and Prevention (CDC), one-third of all U.S. adults are obese, the advent of a new medical device for treatment is news that is garnering a great deal of attention.

How Does It Work?

The Maestro Rechargeable System works by targeting the nerve pathway between the brain and the stomach that exerts control over feelings of hunger and fullness. It consists of an electrical pulse generator that is rechargeable, along with wire leads and electrodes. These are implanted surgically into the abdomen. It then sends electrical impulses to the vagus nerve, which helps regulate stomach emptying and sends signals to the brain that the stomach is either feeling empty or full.

According to EnteroMedics Inc., the company that makes the device, the Maestro Rechargeable System blocks signals that the vagus nerve would ordinarily send to the brain, thus reducing feelings of hunger and making patients feel full earlier than they would otherwise.

For Whom Is It Intended?

According to the FDA, this medical device has been approved for adults (age 18 and older) who have a body mass index (BMI) of 35 to 45, with at least one obesity-related medical condition, such as type 2 diabetes or obstructive sleep apnea.The FDA has specified that these patients should have first demonstrated that they have not been able to lose weight via a weight-loss program.

How Effective Is It?

In one clinical trial that involved patients with a BMI of 35 or greater, those in the experimental group (who received the active Maestro device) saw significant weight-loss results: approximately half of them lost at least 20 percent of their excess weight, and 38% of them lost at least 25% of their excess weight.

What Are the Potential Side Effects?

Side effects that were reported in the clinical trial upon which approval was based included: nausea, vomiting, pain at the surgical implantation site, surgical complications, heartburn, chest pain, difficulty swallowing, and belching. As with any surgical operation or procedure, there can be complications, such as infection and bleeding, that result from the procedure itself.

The FDA has noted that, as part of the approval, EnteroMedics must conduct a five-year post-approval study that follows at least 100 patients for five years and collects additional information on the safety and effectiveness of the device.

Balanced Diet and Exercise Still Needed

This device certainly does not eliminate the need for continued attention to a healthy diet low in processed foods and high in fruits and vegetables. Nor does it eliminate the critical need for staying physically active on a daily basis. Both of these health measures are important not only for weight loss, but for preventing all manner of chronic diseases, including heart disease, stroke, diabetes, cancer, and dementia.

Sources:

FDA. News release: FDA approves first-of-kind device to treat obesity. Accessed online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430223.htm on January 16, 2015.

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