In 2015, the FDA approved the Maestro System, a new obesity treatment option which delivers VBLOC Therapy. This vagal blocking device was developed by EnteroMedics of St. Paul, Minnesota.
Obesity treatments typically first focus on diet, exercise and behavioral therapy. In more difficult cases, placement of intragastric balloons or bariatric surgery is performed to insert a lap band or create a bypass.
According to the World Health Organization, “worldwide obesity has increased more than twice since 1980. WHO statistics outlined 1.5 billion overweight adults in 2008,” reported an article in the journal Gastrology. (3)
VBLOC Therapy works by sending electric signals to the vagus nerve in an attempt to block messaging from the brain and the stomach. The vagus nerve is involved in stimulating the muscles that help empty the stomach, and in the secretion of digestive enzymes.
It is possible that a delay in digestion may make one feel full longer and less hungry, but the exact mechanism of VBLOC is unknown, according to NPR.com.
Vagus nerve stimulation has been used to treat people with delayed emptying of the stomach called gastroparesis and for other conditions such as depression and epilepsy.
However, “EnteroMedics' Maestro System has become the first obesity device to be approved by the United States Food and Drug Administration in ten years,” according to gizmag.com. The last product approved was the Realize adjustable gastric band.
The VBLOC system must be surgically implanted in an outpatient procedure, but it is fully reversible. A controller attached to a battery outside the body adjusts impulses to the device.
VBLOC has been used in Australia since 2011, and is “now approved by the Food and Drug Administration for weight loss in adults with a BMI of 40 to 45 kg/m2 or a BMI of 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels,” according to the enteromedics.com.
JAMA reported on the clinical trial of the device in their September, 2014, issue. “One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device.” The active group lost about 9 percent of their total body weight, while the sham group lost about 6 percent. (4)
NPR noted that side effects occurred in about 4 percent of participants. This included abdominal pain, heartburn, pain coming from the electrode placement, and surgical complications.
The study goal had been for the test group to lose 10 percent more than the placebo group, but the Gastroenterology-Urology Devices Panel of the FDA Advisory Committees still approved the device, finding that the benefits were still high enough to meet certain standards.
Even though it has been approved, the FDA is requiring EnteroMedics to monitor the weight loss results of at least 100 more patients for more than five additional years. This is intended to collect more data to determine effectiveness, safety and other side effects.
NPR reported that the price of the VBLOC will be comparable to other bariatric procedures, about $10,000 to $30,000. The company will be seeking ways for patients to get insurance coverage for the device and its insertion.
Sources:
1) Implant treats obesity by blocking hunger signals. Gizmag.com. Retrieved January 3, 2016.
http://www.gizmag.com/implant-treats-obesity-by-blocking-hunger-signals/...
2) A Weight-Loss Device Aims To Curb Hunger By Zapping A Nerve. NPR.com. Retrieved January 3, 2016.
http://www.npr.org/sections/health-shots/2015/01/16/377428448/a-weight-l...
3) Mintchev, Martin P. Gastric Electrical Stimulation for the Treatment of Obesity: From Entrainment to Bezoars—A Functional Review. ISRN Gastroenterology. Volume 2013 (2013), Article ID 434706, 15 pages.
http://dx.doi.org/10.1155/2013/434706
4) Ikramuddin, Sayeed MD et al. Effect of Reversible Intermittent Intra-abdominal Vagal Nerve Blockade on Morbid Obesity. The ReCharge Randomized Clinical Trial. JAMA. 2014;312(9):915-922. doi:10.1001/jama.2014.10540.
http://jama.jamanetwork.com/article.aspx?articleid=1900511
5) Enteromedics:
http://www.enteromedics.com/default.asp
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues.
Edited by Jody Smith