The EMPOWER Study, which is currently enrolling patients at 10 of its projected 15 clinical sites, is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of investigational VBLOC(TM) vagal blocking therapy using the Maestro(TM) System in obese patients. VBLOC Therapy is designed to empower weight loss by promoting earlier feelings of fullness and reduced hunger while minimizing the side effects and complications associated with existing surgical options and preserving the individual's normal anatomy... EnteroMedics' Press Release -
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Monday, March 10, 2008
EnteroMedics, Expansion of EMPOWER Pivotal Study for Obesity to 300 Patients
Feb 26, 2008 - EnteroMedics Inc., (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced that the Food and Drug Administration (FDA) has granted approval for the expansion of its pivotal clinical trial, known as the EMPOWER Study, from 220 patients to 300 patients. Full enrollment in the EMPOWER Study is expected in the first half of 2008, consistent with previous projections, despite expansion of the study.