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EnteroMedics receives expanded obesity CE mark to include treatment of type 2 diabetes
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EnteroMedics Inc. today announced that its CE mark for the Maestro rechargeable system for obesity has expanded to include the management of type 2 diabetes through improved glycemic control, according to a company press release.
“Diabetes and obesity are among the biggest public health challenges of the 21st century,” Ken Fujioka, MD, director of the Center for Weight Management in the division of Diabetes and Endocrinology at Scripps Clinic, said in the release. “The relationship between these two diseases is well understood and the reason why novel treatment options like VBLOC Therapy, which target multiple metabolic mechanisms, are needed to not only effectively treat obesity, but offer the patients the opportunity to improve their glycemic control.”
Ken Fujioka
The original CE mark was received in 2009 for the treatment of obesity. The expansion was supported by data from multiple clinical trials, including the DM2 ENABLE Study of VBLOC vagal blocking therapy that was delivered by the system in obese patients with diabetes. The safety profile of the recent clinical trial is similar to that of other clinical trials testing the system.
“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 VBLC Therapy,” Mark B. Knudson, PhD, president and CEO of EnteroMedics, said in the release. “This certification allows us to emphasize the clinical benefits of the Maestro System beyond just weight loss to include its effects on the serious comorbidities of obesity, in key markets around the world.”