EnteroMedics has reported ReCharge study results of its VBLOC vagal blocking therapy, designed for the treatment of obesity.
The pacemaker-like Maestro system delivers VBLOC 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 pivotal, prospective, double-blind, sham-controlled study, which had enrolled 239 patients, has randomized them to receive treatment by either implanting a fully functional device with leads to the vagus nerve (treated) or a device without leads to the vagus nerve (sham control).
The study met its primary safety endpoint of a statistically significant excess weight loss (EWL) in 24.4% of patients, with 52.5% of patients achieving at least 20% EWL.
The company said though the trial met its primary safety endpoint, it did not meet its predefined primary efficacy measures.
The company is planning to use the safety and efficacy data of VBLOC therapy to file a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) in the second quarter of 2013.
In addition, the company plans to pursue approval for other indications including obesity-related diabetes and hypertension, outside the US.