By Rita Rubin
WebMD Health News
Jan. 16, 2015 -- The FDA just approved the first new obesity device since 2007.
The Maestro Rechargeable System is a pacemaker-like implant that sends electrical pulses to the vagus nerve. The nerve extends from your brain to your stomach. It's involved in signaling the brain about whether the stomach is full or empty.
A committee of outside advisors to the FDA had concluded that the benefits of the Maestro System outweighed its risks. Most of the panel members agreed that the device was safe, but they were less enthusiastic about whether it worked: Four voted “yes” and five voted “no.”
WebMD asked two obesity experts involved in clinical trials of the device as well as the manufacturer, EnteroMedics, about how the Maestro System is supposed to be used and who might benefit.
Q. What parts make up the Maestro System?
A. It consists of a pacemaker-like electrical pulse generator, wire leads, and electrodes that are implanted in the abdomen. This surgery is a 60- to 90-minute outpatient procedure done while you're under general anesthesia, says EnteroMedics spokeswoman Jody Dahlman.
Q. How does it work?
A. The system is programmed to deliver a pulse -- 5 minutes on and 5 minutes off -- to the vagus nerve during your waking hours, and it's supposed to turn off during the hours you sleep, Dahlman says.
Q. Who's a candidate for the Maestro System?
A. The FDA approved the device for the treatment of obese adults who have a body mass index (BMI) of at least 40, and for those with a BMI of at least 35 who have an obesity-related condition, such as high blood pressure or high cholesterol. Candidates are supposed to have tried to lose weight in a supervised weight-management program within the previous 5 years.
But once the FDA approves a device or a drug, doctors are free to prescribe it to any patient they think might benefit. The device could prove to be useful in helping extremely obese people lose some weight so they can more safely undergo gastric bypass surgery, says Caroline Apovian, MD. She's the director of nutrition and weight management at Boston Medical Center. The Maestro System also might help enhance weight loss after gastric bypass surgery, she says.
source : New Device to Treat Obesity: Is It for You?
