FDA Approves Device to Treat Obesity

The U.S. Food and Drug Administration (FDA) has approved a new device to treat obesity, the first since 2007, sending shares of its manufacturer, EnteroMedics Inc, up as much as 74 percent.

Known as the Maestro Rechargeable System, the device controls hunger and feelings of fullness by targeting the nerve pathway between the brain and the stomach. It is implanted surgically into the abdomen and works by sending electrical pulses that interfere with the activity of the vagus nerve, which signals to the brain that the stomach is empty. The device can be recharged by the patient and healthcare professionals can adjust its settings using external controllers.

“VBLOC Therapy offers an entirely new approach to the treatment of obesity,” said Scott Shikora, M.D., F.A.C.S., EnteroMedics’ chief consulting medical officer. “By blocking signals along the nerves that connect the brain and stomach, VBLOC 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.”

A 12-month clinical study showed that patients implanted with the device lost 8.5 percent more weight than the control group. That did not meet the main goal of the clinical trial, which was to show weight loss of 10 percent or more. But an FDA advisory panel considered additional data and concluded that the benefits of the device outweighed the risks for certain patients.

The device is approved to treat patients aged 18 and older who have not been able to lose weight with a weight-loss program, who have a body mass index (BMI) of 35 to 45 and have at least one other obesity-related condition, such as Type II diabetes. A person with a BMI of 30 or more is considered obese.

“FDA approval of VBLOC Therapy is a transformational event for not only EnteroMedics but more importantly, for the people with the disease of obesity that have been waiting for a new option,” said Mark B. Knudson, Ph.D., EnteroMedics’ president and CEO. “The Maestro System fills a gap in the currently available treatment options, offering clinically meaningful weight loss without the fear or many of the side effects associated with existing bariatric options. We thank the many patients, and their families, who have participated in the clinical trials of VBLOC Therapy. We are also grateful to the physicians and healthcare providers who have worked with us on these clinical trials, our employees, as well as to the FDA for their efforts in making this technology available.”

Despite the approval, the prospects for the device will depend on insurers being willing to pay for it, a process that could take up to two years, analysts estimate.

As part of the approval, the company must conduct a five-year study that will follow at least 100 patients and collect additional safety and effectiveness data.

Serious side effects reported in the clinical study included nausea, pain, vomiting and surgical complications.

More than a third of U.S. adults are obese, according to the Centers for Disease Control and Prevention, placing them at greater risk of heart disease, stroke, diabetes and cancer. The estimated annual cost of obesity in the U.S. was $147 billion in 2008, accounting for more than twice previous estimates, approximately 21 percent, of U.S. healthcare costs.

Other surgical treatments for obesity include gastric banding systems that limit the amount of food that can be eaten at one time.

Based in St. Paul, Minn., EnteroMedics is focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. EnteroMedics’ Maestro Rechargeable System has received the CE Mark and currently is listed on the Australian Register of Therapeutic Goods.