EnteroMedics' Maestro System has become the first obesity device to be approved by the United States Food and Drug Administration in ten years. The device, which the company compares to a pacemaker, is designed to block signals in the nervous system to reduce feelings of hunger.
Obesity is, excuse the phrasing, a growing problem across the world. It is estimated that one third of Americans are clinically obese. While eating less is may present the simplest and most obvious solution for many, combating obesity or stimulating weight loss, especially in the morbidly obese, is not a linear problem. Often it is simply not practicable or effective for those treating obese patients to recommend diet and exercise, and more drastic treatments such bariatric surgery are too invasive for some patients or may have other adverse effects.
The now FDA approved Maestro System, which has been in use in Australia since mid-2011, is implanted via an outpatient procedure. By applying electrical pulses in what EnteroMedics calls VBLOC vagal blocking therapy, it is designed to interfere with signals between the stomach and the brain along the vagus nerve, which regulates the digestive system. Like other approaches to suppressing appetite , the desired result is to decrease feelings of hunger or induce a sense of satiety. The implanted system is connected to a battery which must be regularly recharged by the patient.
"VBLOC Therapy offers an entirely new approach to the treatment of obesity," says Scott Shikora, MD, FACS, EnteroMedics’ Chief Consulting Medical Officer. "By blocking signals along the nerves that connect the brain and stomach, VBLOC to reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss."
The procedure is fully reversible and non-invasive and, according to the company, the system allows patients to "lose weight without lifestyle compromises," it is not designed to suit everyone who needs to shed a few pounds. EnteroMedics specifies that the device is "for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years."
While clinical trials showed that the device is effective, the FDA notes in its pre-approval report that the trial patients lost 8.5 percent of their excess weight compared to those implanted with a sham device, falling short of the 10 percent requirement. Despite this the FDA has approved the device, which will only be implanted at specially chosen clinics by surgeons who have undergone both implant and explant certification.
The same paper also noted that in longer term weight loss patients it is important that lifestyle and diet habits are also changed, along with any use of a device.