The double-blind, multicenter, parallel-group, randomized trial is designed to assess the effectiveness and safety of VBLOC vagal blocking therapy, delivered via the company’s Maestro Rechargeable (RC) System during treating obesity.
VBLOC Therapy is designed to control both hunger and fullness by regulating the primary nerve which controls the digestive system.
EnteroMedics president and CEO Mark Knudson said with this, they begin the 12 month blinding period of the trial in continuation of their plans for US registration.
"This milestone achievement, combined with approval for ARTG listing by the TGA of most of the components of the Maestro System and European CE mark certification, significantly advanced our commercialization efforts for this patient-friendly therapy in 2011," Knudson said.
EnteroMedics said it has also received approval for six of the eight remaining individual class III components.
