US-based EnteroMedics' CE Mark for the Maestro Rechargeable (RC) system for obesity has been expanded to include the management of type 2 diabetes mellitus through improved glycemic control.
Initially, the Maestro System secured CE Mark in 2009 to treat obesity and is listed on the Australian Register of Therapeutic Goods.
The CE Mark granted by the European Commission (EC) provides marketing approval in the countries of the European Economic Area, and that is recognised by many nations, including Australia.
Scripps Clinic division of diabetes and endocrinology director of the Center for Weight Management Ken Fujioka said: "Diabetes and obesity are among the biggest public health challenges of the 21st century.
"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 CE Mark for the diabetes indication was based on data from the company's multiple clinical trials, including the DM2 ENABLE trial of VBLOC vagal blocking therapy delivered via the Maestro RC System in diabetic subjects with obesity.
EnteroMedics president and chief executive officer Mark Knudson said: "The expansion of our CE Mark certification for the Maestro System recognises the clinically meaningful, sustainable improvement in glycemic control observed in type 2 diabetes patients with obesity receiving VBLOC therapy.
"This certification allows us to emphasise 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 international, open-label, prospective, multi-centre DM2 trial evaluated the safety and efficacy of VBLOC vagal blocking therapy delivered via the Maestro RC System in 28 diabetic patients with obesity.
During the trial, patients were evaluated by measuring average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure, following device activation.
So far, no deaths or unanticipated adverse device effects have been reported during the VBLOC-DM2 ENABLE trial and the safety profile is similar to that seen in other VBLOC clinical trials.
The company develops medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders.