For the first time in nearly a decade, the FDA has approved a medical device for treating obesity, and this one is implanted. The device is called the Maestro Rechargeable System, or VBLOC, and it is manufactured by EnteroMedics, which is in St. Paul, MN.
The system works by stopping hunger pangs from going from the stomach to the brain. It does this by blocking the impulses sent from the vagus nerve. The implanted device is similar to a cardiac pacemaker in that it is charged and then controlled remotely. The Maestro Rechargeable System uses an external battery, which needs to be recharged weekly.
The VBLOC system took 12 years to develop. The device is variable and can provide different levels of stimulation, depending on how much help the patient needs with their obesity. At the present time, the doctors will decide what level to set the device on, but later, patients will need to make the decision.
A strong advantage of the system is that it is much less invasive than bariatric surgery. The FDA sees the need for more options given to Americans because there are now more than one-third of them who are obese. As a result, their obesity makes them candidates for other serious health problems such as stroke, type 2 diabetes, heart disease, and certain kinds of cancer.
One reason for allowing the VBLOC device to reach the American market is to give doctors and patients more options to lose the extra weight, said William Maisel, M.D., M.P.H., who is the deputy director for science, and the chief scientist at the FDA’s Center for Devices and Radiological Health. He also says that it will help provide both with “comprehensive obesity treatment plans.”
When the FDA approved the implanted electronic obesity device, they put limitations on those that it can be used by. It has been approved for use on people who are obese and have a body mass index of 35 to 45, and they must be at least 18 years old. They must also have other medical problems that are related, such as heart disease or diabetes. Candidates must also have tried and failed to lose weight in some kind of weight loss program.
The trial study said that the FDA looked at involved 157 patients who used VBLOC, and there were 76 patients who served as the control group who were given the device but it did not work. After one year, it was discovered that the group using VBLOC lost 8.5 percent more than the control group, although the manufacturer had hoped they would lose as much as 10 percent more.
The company also reported on those who regained weight after the trial. They stated that the people that had the phony implants had gained back about 40 percent of the weight they lost. Those who had the device seemed to be able to maintain their weight loss.
The VBLOC device is already approved for sale in Europe and Australia. At the same time that the FDA approved the implanted obesity device, they also asked EnteroMedics to inform them after they have continued studying it for five years, whether or not there are any side effects created by continuously stimulating the vagus nerve, and other information the nerve may be sending to the brain.
By Mike Valles