EnteroMedics has announced that its CE Mark for the Maestro Rechargeable (RC) system for obesity has been expanded to include the management of T2DM through improved glycaemic control. The Maestro System initially received CE Mark in 2009 for the treatment of obesity (BMI30-55) 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 recognises the clinically meaningful, sustainable improvement in glycemic control observed in Type 2 diabetes patients with obesity receiving VBLOC Therapy," said Dr Mark B Knudson, President and CEO of EnteroMedics. "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."
EnteroMedics' VBLOC vagal blocking therapy, delivered via the Maestro Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses.
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.
DM2 ENABLE study
The DM2 ENABLE Study is an international, open-label, prospective, multi-centre 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 EWL, HbA1c, 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 XIX IFSO World Congress [1], 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<0.0001) 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.
"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 glycaemic control."
EnteroMedics' PMA application for VBLOC Therapy, which was accepted for review by the FDA in July 2013 [2], contains data from the company's ReCharge Pivotal Study.
