FDA Approves New Device in Bariatric Surgery

Patient Expert

Maestro "Appetite Pacemaker"Looking back to when I was struggling with obesity, I can remember going about some bit of business while ** mindlessly eating**.   I would shovel high carb trash into my mouth: chips, cookies, chocolate, whatever. I wasn't even hungry, just habitual.  There were also countless instances when I would get caught up in thoughts of a particular food until the want for that food became a must. Hunger had nothing to do with it. The end result of all this was that I became obese.

My gastric bypass was a good tool-along with exercise, nutrition and a good support network-to keep the weight off. Every tool that helps push back against obesity is a good one, and there is now a new addition to the bariatric toolbox.** It is the "appetite pacemaker," which the manufacturer claims is the newest treatment in bariatric surgery.**** FDA ApprovalThe Maestro System** obesity treatment device is not available just yet, but the manufacturer EnteroMedics is working on it. On the up side, the FDA has approved it, making it** the first new obesity device approved by the FDA in over seven years**. The downside is that Maestro has a few bugs in it. Said bugs are that** no one is sure how it works** or, for that matter, how well it works at all.

Surgically ImplantedThe Maestro System is minimally-invasively surgically implanted under the skin of the abdomen. Attachments are placed at the point where the esophagus meets the stomach. The VBLOC therapy delivered via the Maestro System is meant to interfere with a central nerve that controls the heart and digestive track.** VBLOC interrupts hunger signals from the brain to the stomach** and is manually controlled.

_Video demonstrating VBLOC therapy delivered via the Maestro ® System, a new treatment in bariatric surgery according to EnteroMedics.his blocking action reduces the feeling of hunger and promotes feelings of fullness, although it is not clear if the device interferes with hunger or is acting in some other way. Specifics as to how the device actually works are something of a puzzle at this point.

How Much Weight Will I Lose?Right now the manufacturer, EnteroMedics, is having problems getting their product to market. While it works safely in patient trials, the reported weight loss is about 8.5% of excess weight compared to people who had a placebo device implanted.** The FDA wants a rate of 10% or more** but has still approved it for potential future use in patients 18 years old or older who have not been able to lose weight in a weight loss program.** Patients must have a BMI of 35-45 and at least one obesity related health condition, such as type 2 diabetes in order to use the device. -Year Stud condition of the FDA approva**l is that a five year post-approval study of at least 100 patients be done to collect additional data about safety, effectiveness, weight loss, adverse events, and surgical revisions.

Insurance Coverage

Current predictions are that insurance companies will be in no special hurry to cover this obesity treatment device when it is on the market.

Living larger than ever,** My Bariatric Lifisit me on  ** MyBariatricLife.org**,** ** Flickr**,  Vimeo,  Twitter,  YouTube,** StumbleUpon,** ** Google+**** iew my** ** Borne  Appétit  recipe collection on Pinterest**

**References:  **** NBC News**