EnteroMedics has published 2.5-year diabetes, hypertension and weight loss data from the company’s DM2 Enable study of vagal blocking (VBLOC therapy) delivered via the Maestro Rechargeable (RC) system.
Maestro RC system delivers vagal blocking therapy through two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve, just above the junction between the oesophagus and the stomach.
The international open-label prospective multicentre DM2 study enrolled 28 diabetic individuals with obesity to assess the safety and efficacy of the vagal blocking (VBLOC therapy).
Following device activation, the trial measures average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure.
The DM2 trial demonstrated that a change in mean arterial pressure and diastolic blood pressure showed sustained improvement, with reductions of 11.5mmHg and 13.2mmHg at 30 months from baselines of 99.1 and 85.9 respectively.
Study results also reported that the change for HbA1c and fasting plasma glucose were -0.8 and -29 from a baseline of 7.7% and 162.8mg/dl, respectively.
EnteroMedics president and chief executive officer Mark Knudson said the encouraging results from the 30-month follow-up study will support the company’s plan to add the treatment of diabetes and hypertension to the existing obesity CE mark indication.
Flinders University in Adelaide, Australia, surgery professor James Toouli said the results from independent studies about the effects of weight loss surgery on type two diabetes are reflected in the 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.