With 79 million adults considered obese in the United States, it's clear that there's something of a problem when it comes to obesity in the United States. While debate will fairly rapidly ensue about just how big a problem it actually is, those interested in doing something about it yet not having much luck by conventional means in the healthcare market may have just what's needed in the new Maestro Rechargeable System—recently approved for marketing in the U.S. by the Food and Drug Administration (FDA).
A product of St. Paul, Minnesota firm EnteroMedics, the Maestro represents the first weight loss device approved for use in the United States since 2007, a fairly pronounced achievement given that the FDA has approved four separate medications for weight loss in just the last two and a half years. As for the “how it works” part, the idea is fairly simple, if a bit drastic. The Maestro is implanted just above the stomach, and from there, a regulator runs under the skin near the ribcage to interact with the vagus nerve, the nerve that sends signals up to the brain related to appetite.
Specifically, the Maestro interrupts signals that cause the stomach to relax and expand in order to receive an influx of food, one of the key components of hunger. If the stomach remains contracted, it essentially reduces the appetite. The system is approved for use in adults that have a body mass index (BMI) between 35 and 45, and have at least one obesity-related condition like type 2 diabetes, which should reduce some of the false-positives that come about as a result of using the BMI alone.
However, a clinical trial of the Maestro, which lasted 12 months, has some sound numbers to back it up. Fully 52.5 percent of subjects with the device lost at least 20 percent of excess weight, and 38.3 stepped that up to lose at least 25 percent. Those who think the placebo effect might have gotten involved, meanwhile, have some facts to consider; most notably, those subjects who received an active device lost about 8.5 percent more weight than those whose Maestro wasn't activated.
Given that the device itself is set to cost between $20,000 and $30,000 to install and activate, it's clear that there will be some problems of affordability. But private insurers have already been in negotiations with EnteroMedics, and Medicare reportedly considers it an “exploratory” procedure, with coverage possibly available before the end of the year.
Indeed, insurers should be eager to get this into practice; after all, how many times have we heard about the problems obesity causes? With a device such as this, that is clearly having an impact on obesity figures, why wouldn't insurers want to pay one price now to prevent so many other prices from occurring down the road? Maybe it's still too new to have much of an impact. Maybe there's something else at work here. But it certainly seems like the Maestro may have a handle on the whole obesity issue, and that should prompt plenty of interest.
Only time will tell just how far the Maestro can go, but with insurers at least somewhat interested and users feeling likewise, we should be seeing more of these in active service in a fairly short time span.
Edited by
Maurice Nagle
