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

News releases and media advisories

For immediate release:
1/10/2008

Pamela DiSalvo Lepley
VCU Communications and Public Relations
(804) 828-6057
pdlepley@vcu.edu

Helen Shik
Schwartz Communications
(781) 684-0770
enteromedics@schwartz-pr.com

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

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.

Patients interested in participating in the clinical research study may call the nurse-staffed information line at 1-866-97-VLBOC (1-866-978-2562) for more information and to determine eligibility. Additional information can be found on the Web site: www.EMPOWERstudy.com.

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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.

About the Virginia Commonwealth University Medical Center:

The Virginia Commonwealth University Medical Center is one of the nation’s leading academic medical centers and stands alone as the most comprehensive academic medical center in Central Virginia. The medical center includes the 780-bed MCV Hospitals and outpatient clinics, MCV Physicians — a 600-physician-faculty group practice, and the health sciences schools of Virginia Commonwealth University. The VCU Medical Center, through its VCU Health System, offers state-of-the-art care in more than 200 specialty areas, many of national and international note, including organ transplantation, head and spinal cord trauma, burn healing and cancer treatment. The VCU Medical Center is the site for the region’s only Level 1 Trauma Center. As a leader in healthcare research, the VCU Medical Center offers patients the opportunity to choose to participate in programs that advance evolving treatment, such as those sponsored by the National Cancer Institute through VCU’s Massey Cancer Center, Virginia’s first NCI-designated cancer center. The VCU Medical Center’s academic mission is supported by VCU’s health sciences schools of medicine, allied health, dentistry, pharmacy and nursing.