St. Paul, Minnesota – Officials from EnteroMedics Inc., developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, 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, 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 CEO 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.
Source: EnteroMedics Inc.