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VCU Bariatric Surgery Program offers VBLOC Therapy procedure

Posted by March 31, 2016

VBLOC Therapy is delivered through the Maestro® Rechargeable System, a pacemaker-like implant, and is non-invasively programmed by a physician to best meet the individual patient’s needs. It also can be adjusted, deactivated, reactivated or completely removed if desired. The implantation of the Maestro System does not alter normal digestive system anatomy and allows for a normal diet and lifestyle.

The Maestro® Rechargeable System has received Food and Drug Administration (FDA) approval as well as CE Mark in Europe, and has been listed on the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA) for supply in Australia.

VBLOC® vagal blocking therapy is delivered via electrodes that are placed in contact with the trunks of the vagus nerves just above the junction between the esophagus and the stomach. The scheduled delivery of the intermittent blocking of the vagus nerve is customized for each patient. The device intermittently blocks vagal nerve signals throughout the patient’s waking hours. The Maestro® System is recharged using an external mobile charger and transmit coil worn by the patient. The device can be non-invasively programmed, and it can be adjusted, deactivated, reactivated or completely removed if desired.

The therapy provided by the Maestro device is called VBLOC, which stands for vagal nerve blocking. To control both hunger and fullness, the device intermittently blocks signals from the vagus nerve, the primary nerve regulating the digestive system. Those patients choosing not to pursue surgery may be interested in this novel technology. The FDA approved the Maestro device for use in patients 18 years and older who have a body mass index (BMI) of 35 to 45 and at least one other obesity-related condition, such as type 2 diabetes. Candidates for the device must also have failed at least one supervised weight management program within the past five years.

See Press Release: FDA approves first-of-kind device to treat obesity

OVERVIEW:

New devices are essential to keeping innovation in the United States and to help us meet the needs of patients with obesity.

VBLOC represents an innovative, new approach to the treatment of obesity. VBLOC works by blocking signals along the nerves that connect the brain and stomach, reducing feelings of hunger and promoting earlier feelings of fullness. This is helpful for people with obesity to reduce their calorie intake, and promote safe, healthy, and durable weight loss.

vagus nerve diagramImplanted Maestro device blocks vagal nerve signals, curbing appetite.

The Maestro device is like a pacemaker and is implanted in the abdomen in an outpatient procedure. VBLOC therapy doesn't surgically change or restrict the digestive system, no barriers to prevent absorption of nutrients, and is a reversible treatment which allows patients to lose weight by a new mechanism.

Insurance typically does not cover new procedures until more data are available, however, new technologies for weight loss are promising as evidenced by this recent FDA approval.

CLINICAL TRIAL:

In 2008, VCU Surgical Weight Loss Center conducted clinical trials of this new bariatric treatment known then as VBLOC therapy.

Smith, T., Jan. 2008, VCU Studies Disk for Weight Loss
Richmond Times Dispatch

Existing weight loss procedures may not be right for everyone but with new therapies, additional choices are made available to more patients with obesity.

Mark A. Talamini, MD, professor and chairman of surgery at Stony Brook Medicine, chaired an FDA advisory panel in October, advising the FDA on the results of the clinical trial involving the Maestro device:

This trial was important, in that the control group underwent a sham operation, and were treated exactly as if the device were in place. The experimental group, those patients that had the devise in place, had good results. What was perplexing was that the control, placebo group also had surprisingly good results. This made the trial challenging for the expert panel members to evaluate.

"In the end, I am glad for several reasons that the FDA elected to approve the Maestro device. First, obesity is a huge public health problem in the United States, and we need all of the tools possible in our arsenal to help obese patients. Second, if innovative devices like this do not come to market, it will discourage other ideas, startup companies, and venture capital from participating in this critical arena.

Read the FDA announcement about the Maestro device. To learn about clinical trials and other options currently available at the VCU Surgical Weight Loss Center, please call 804-828-8000.


The VCU Surgical Weight Loss Center is a Bariatric Surgery Center of Excellence designated by the American Society for Bariatric Surgery and the Surgical Review Corporation.

The ASBS Center of Excellence designation recognizes surgical programs with a demonstrated track record of favorable outcomes in bariatric surgery
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