EnteroMedics announces vagal blocking therapy trial data

10 February 2013 (Last Updated February 10th, 2013 18:30)

EnteroMedics has reported clinical study results of its VBLOC vagal blocking therapy used for the treatment of obesity.

EnteroMedics has reported clinical study results of its VBLOC vagal blocking therapy, used for the treatment of obesity.

Using the company's proprietary technology, 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, ReCharge, had enrolled 233 patients and randomised 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).

"Using the company's proprietary technology, 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 company said that although the trial met its primary safety endpoint, it did not meet its predefined primary efficacy measures.

However, the study did demonstrate statistically significant excess weight loss (EWL) of 24.4%, with 52.5% of patients achieving at least 20% EWL.

EnteroMedics president and chief executive officer Dr Mark Knudson said; "Based on these compelling results, and the totality of our clinical experience with the Maestro System, which now includes more than 600 patients worldwide, we believe EnteroMedics is well positioned to deliver this novel therapy to people with obesity in the US."

The company said it 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.