EnteroMedics Closes VBLOC Therapy Pre-PMA Meeting with FDA

EnteroMedics Inc. ETRM, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company completed a pre-PMA (Premarket Approval) application meeting with the U.S. Food and Drug Administration (FDA) on May 15, 2013 regarding the Maestro(R) Rechargeable System's VBLOC(R) vagal blocking therapy as a treatment for obesity. In the meeting, the FDA indicated that, subject to acceptance of the application and validation and detailed review of the submitted data by the FDA, the Company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The Company expects to submit a PMA for the Maestro Rechargeable System, based on the ReCharge Pivotal Trial, in the second quarter of 2013.