FDA approves expansion of EMPOWER study for obesity
The FDA has granted EnteroMedics Inc. approval for the expansion of its pivotal clinical trial, known as the EMPOWER Study, from 220 patients to 300 patients. Full enrollment in the study is expected to be completed in the first half of 2008. The EMPOWER Study is being conducted to evaluate the safety and effectiveness of investigational VBLOC™ vagal blocking therapy using the Maestro™ System in obese patients. VBLOC Therapy promotes earlier feelings of fullness and reduced hunger and also minimizes the side effects and complications related to existing surgical options and preserving the individual’s normal anatomy.
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