VCU Announces Selection as Clinical Research Study Site for Investigational Obesity Therapy

By Pamela DiSalvo Lepley and Helen Shik

Virginia Commonwealth University Medical Center announced today that it has been chosen as a clinical research site in a national pivotal clinical study called EMPOWER, to evaluate the safety and effectiveness of an investigational device providing VBLOC™ Therapy, for the treatment of obesity, according to James Maher, M.D., chair, Division of General Surgery and lead investigator at the VCU Surgical Weight Loss Center.

"Obesity is now a global medical concern and is considered to be one of the leading causes of preventable death, second only to smoking," said Dr. Maher.

Data gathered by the National Institutes' of Health (NIH) National Health and Nutrition Examination Survey (NHANES) 2001-2004 concluded that about two-thirds of American adults are overweight and almost one-third are obese. Overweight is defined as a Body Mass Index (BMI) of 25, with obesity defined as a BMI of 30. Morbid obesity is defined as a BMI of 35 or over. Obesity is associated with greater health risks for hypertension, sleep apnea, high cholesterol, osteoarthritis and certain types of cancer.

Unlike other surgical procedures that address obesity, the investigational device that delivers VBLOC Therapy does not alter the stomach's anatomy. Instead, laparoscopically implanted electrodes have been designed to block the vagus nerve and the signals carried between the brain and the digestive system that control sensations of hunger, satisfaction and fullness.

Potential participants may include men and women between the ages of 18 and 65 who have a BMI (body mass index) between 35 and 45. Those with a BMI of less than 40 must also have been diagnosed with sleep apnea, high cholesterol, obesity-related cardiomyopathy or hypertension. Those with Type 2 diabetes may also be eligible at selected study sites. In addition to the device, participants will receive education and advice on diet, exercise and behavior modification.

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Saint Paul, Minnesota-based EnteroMedics Inc. is dedicated to "orchestrating obesity solutions." Based on their in-depth analysis of how the vagus nerve affects food intake and processing, EnteroMedics developed the investigational device that delivers VBLOC Therapy, intended to aid those who suffer from obesity. For more information on EnteroMedics, please visit their website at www.enteromedics.com.