EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that its CE Mark for the Maestro® Rechargeable (RC) System for obesity was expanded to include the management of Type 2 diabetes mellitus through improved glycemic control.
"Diabetes and obesity are among the biggest public health challenges of the 21st century," said Ken Fujioka, Director of the Center for Weight Management, Scripps Clinic division of Diabetes and Endocrinology. "The relationship between these two diseases is well understood and the reason why novel treatment options like VBLOC Therapy, which targets multiple metabolic mechanisms, are needed to not only effectively treat obesity, but offer patients the opportunity to improve their glycemic control."
The Maestro System initially received CE Mark in 2009 for the treatment of obesity (Body Mass Index of 30 to 55) and is listed on the Australian Register of Therapeutic Goods. CE Mark is a conformance mark granted by the European Commission that provides marketing approval in the countries of the European Economic Area, and that is recognized by many nations, including Australia.
"The expansion of our CE Mark certification for the Maestro System recognizes the clinically meaningful, sustainable improvement in glycemic control observed in Type 2 diabetes patients with obesity receiving VBLOC Therapy," stated Mark B. Knudson, Ph.D., President and Chief Executive Officer of EnteroMedics. "This certification allows us to emphasize the clinical benefits of the Maestro System beyond just weight loss to include its effects on the serious co-morbidities of obesity, in key markets around the world."
The CE Mark for the diabetes indication was supported by data from the Company's multiple clinical trials, including the DM2 ENABLE Study of VBLOC® vagal blocking therapy delivered via the Maestro RC System in diabetic subjects with obesity.
VBLOC-DM2 ENABLE Study Data
The DM2 Study is an international, open-label, prospective, multi-center study designed to evaluate the safety and efficacy of VBLOC® vagal blocking therapy delivered via the Maestro® RC System in 28 diabetic subjects with obesity by measuring average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure, following device activation. To date, no deaths or unanticipated adverse device effects have been reported during the VBLOC-DM2 ENABLE Study and the safety profile is similar to that seen in other VBLOC clinical trials.
As reported at the 19th Annual Meeting of the International Federation for the Surgery of Obesity and Metabolic Disorders, the metabolic effects of VBLOC Therapy at three years in diabetes, hypertension and weight loss were consistent with previous findings from other time points and are considered medically meaningful improvements. The reductions at 36 months from baseline in HbA1c (from 7.6% to 7.0% (p=0.04)), fasting plasma glucose (from 155.6 mg/dl to 131.25 mg/dl (p=0.0145)) and excess weight loss of 24.3% (p<.0001) continue to show the long term sustainability of VBLOC Therapy as a weight loss and promising metabolic disease intervention. In addition, of the 18 patients who were being treated with one or more diabetic medications at the start of the trial, 83% had either completely stopped taking their medication, reduced the dose of medication, or had no increase in the amount of medication they were taking by 36 months.
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