FDA approves novel device for weight loss

Obesity

The U.S. Food and Drug Administration has approved an implantable device that uses neuroblocking technology to promote weight loss. The device, called the Maestro Rechargeable System, sends intermittent electrical pulses to a specific abdominal nerve. As a result, the nerve activity between the stomach and brain is blocked.

How it aids in weight loss

“By blocking these signals, the stomach does not expand,” says Greg Lea, chief financial officer of EnteroMedics, which manufactures the device. “Therefore, patients do not want to eat as much during mealtime.”

According to Lea, blocking this communication also slows down the digestive process so that food stays in the stomach longer. This, in turn, leaves patients feeling fuller for an extended period of time. The approach is called VBLOC therapy, and it represents the first weight-loss device to be approved by the FDA since 2007.

The device rendered encouraging results in clinical trials. “Across all of our trials, which includes over 600 patients, we have demonstrated an average excess weight loss of 25 percent at 12 months, and have shown that this is durable out past 36 months,” says Lea. “In our most recent trial, nearly 20 percent of our patients lost half of their excess weight.”

The device’s approval is significant as it represents a departure from traditional weight-loss approaches, including restrictive and malabsorptive surgeries. According to Lea, VBLOC therapy offers a safe, effective alternative. The device is implanted through a reversible outpatient procedure that does not alter or restrict the patient’s anatomy. Patients can also continue to eat normally afterward.

The Maestro Rechargeable System has been approved for obese adults with a BMI of 35 to 45 who have been unable to lose weight with other weight-loss programs, according to the FDA. In order to qualify, patients must also have at least one other obesity-related condition.

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