EnteroMedics has reported 2.5-year diabetes, hypertension and weight loss data of its DM2 Enable study of VBLOC vagal blocking therapy.
The international, multi-center, open-label, prospective study, which enrolled 28 diabetic subjects with obesity, was designed to assess the safety and efficacy of Vbloc vagal blocking therapy delivered via the Maestro RC system.
The study includes measuring average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure, following device activation.
The results demonstrated that the metabolic effects at 2.5 years in diabetes, hypertension and weight loss were consistent with previous findings and were all statistically significant.
Flinders University surgery professor James Toouli said recently published results from independent studies about the effects of weight loss surgery on type 2 diabetes are reflected in this study of the Maestro RC System, where reduction in glycemic load and HbA1c, two diabetes indicators, appears independent of weight loss.
"These results are not only significant, but durable, lasting out to 30 months, and show an effect on blood pressure and weight loss, while continuing to demonstrate an excellent safety profile, including cardiovascular safety," Toouli added.
"I look forward to further investigating the potential of Vbloc Therapy in the treatment of obesity, diabetes and hypertension."
EnteroMedics president and chief executive officer Mark Knudson said the results, now at 30 months of follow-up, will support company’s plans to add the treatment of diabetes and hypertension to the existing obesity CE mark indication.
The Maestro RC system delivers Vbloc vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach.
The company said it will present a portion of the data at the 24th Annual Scientific Conference of the Obesity and Surgery Society of Australia and New Zealand being held from 11-13 April 2012 in Darwin, Australia.