How can binge eaters and emotional eaters learn to control themselves and avoid becoming overweight or even obese? Undoubtedly, supplying an answer to this question would make you a millionaire in about two seconds flat since so many of us are in the habit of feeding our feelings... at least on occasion. With the news the Maestro Rechargeable System, a weight loss treatment device, has moved one step closer to Food and Drug Administration (FDA) approval, its creator, EnteroMedics, has become flush with newfound confidence but can the Maestro System offer the same degree of hope and happiness to the obese?
After all, although a key committee of the FDA voted eight to one the Maestro System is safe and voted six to two the device's benefits outweigh its risks, when considering ‘reasonable assurance’ of efficacy, the same committee voted four to five against. Safe but possibly ineffective, concludes the FDA. Meanwhile, EnteroMedics is continuing to pursue this necessary approval in order to being marketing its new product.
How It Works
The Maestro System is based on what EnteroMedics refers to as VBLOC therapy, which is designed to control feelings of hunger and fullness by blocking the nerve which regulates the digestive system. The vagus nerve affects digestion and other activities of the stomach, intestines, and pancreas, primarily by providing two-way communication between the brain and body. After eating, it is signals carried along the vagus nerve that inform your brain you’re no longer hungry. Early research on surgical vagotomy — severing the vagus nerve near the stomach, an operation used to treat peptic ulcers — showed patients losing weight along with their appetites. However, overtime the body compensated and the weight-loss effects disappeared.
Tweaking the theory underlying the vagotomy, EnteroMedics designed VBLOC Therapy to intermittently block vagus nerve signaling using a pacemaker-like device — a "pulse generator" — that is surgically implanted under the skin of the chest wall. While normal digestive system anatomy is preserved, the Maestro delivers high-frequency electrical pulses to leads laid along two trunks of the vagus nerve. In short, it's a neurostimulator, similar to those used for years to manage pain, except this controls hunger pangs. Again, you may very well ask, is controlling the sensation of hunger enough to curb those who eat for pleasure or pain?
Maybe, maybe not, still the clinical trial results don't look too shabby. EnteroMedics demonstrated patients using the Maestro System lost 24.4 percent of their excess weight at one year, which represents a clinically meaningful and statistically significant loss. Importantly, this excess weight loss was sustained out to 18 months. Most participants in the study (52.5 percent) lost 20 percent or more of their excess weight and nearly one-third lost 30 percent or more. Additionally, the researchers observed statistically significant improvements in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate, and waist circumference among participants undergoing treatment.
"Where existing options are clearly failing to address the growing epidemic of obesity, we believe VBLOC Therapy may offer a unique approach to treating obesity,” said Greg Lea, Chief Operating Officer and Chief Financial Officer of EnteroMedics. Unique, for sure, but only FDA approval and a little time will tell if the Maestro can really help emotional eaters and bingers.