Data From EnteroMedics' VBLOC-DM2 ENABLE Study to Be Presented at American Society for Metabolic and Bariatric Surgery Meeting
2010-06-22 07:30 ET - News Release ST. PAUL, MN -- (MARKET WIRE) -- 06/22/10
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that updated clinical results from the Company's VBLOC-DM2 ENABLE (DM2) study will be presented on June 26, 2010 at 11:30 AM PT at the 27th Annual Meeting of the American Society of Metabolic and Bariatric Surgeons (ASMBS), being held June 21-26 in Las Vegas, NV. The Company also announced today updated data from its EMPOWER™ study in obesity.
"The Maestro System has been studied in over 400 people to date, with some patients into their fifth year of follow-up," said President and CEO Mark B. Knudson, Ph.D. "Across a number of studies, we have observed clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures. We are particularly encouraged by the strong, positive feedback from the metabolic and bariatric surgery community."
The Maestro® System, which delivers VBLOC® vagal blocking therapy, continues to meet all of its safety goals, with no therapy-related serious adverse events reported across all of the various study populations.Updated VBLOC-DM2 ENABLE Study Data
The DM2 study is an ongoing feasibility study of the Maestro System in obese patients with Type-2 diabetes mellitus. The study was designed to evaluate the safety and efficacy of the Company's next-generation Maestro RC System. The Maestro RC System is powered by an internal battery recharged via an external mobile charger and transmit coil worn by the patient for a short time each week. Patients in this trial are averaging approximately 14 hours per day of therapy.
"The DM2 study is noteworthy in that we see significant, sustained improvements in glycemic control and blood pressure as well as clinically meaningful weight loss, without a compromise in patient safety," said James Toouli, M.D., professor of surgery at Flinders University in Adelaide, Australia, and one of the study's investigators. "These results are comparable to changes seen with other procedures and do not appear to be dependent only on reduction of the glycemic load."
"The study's glycemic control data are particularly promising, as published research indicates an HbA1c level below 7 percent is associated with fewer microvascular complications and reduced cardiovascular disease," Dr. Toouli added, noting the National Health and Nutrition Examination Survey Data. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 1999-2002. "I look forward to further investigating the potential of VBLOC Therapy in the treatment of obesity and its related co-morbidities."