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Northstar Neuroscience Receives FDA Approval for a Clinical Study of its Cortical Stimulation System for the Treatment of Major Depressive Disorder.

Publication: Business Wire
Publication Date: 14-OCT-08
Format: Online
Delivery: Immediate Online Access

Article Excerpt
Second clinical study to begin enrollment in Q4

SEATTLE -- Northstar Neuroscience, Inc. (NASDAQ: NSTR) today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of a second clinical study of its Renova[TM] Cortical Stimulation System for the treatment of major depressive disorder (MDD). With this approval, the Company expects to begin enrolling patients into its PROSPECT II study this quarter, with preliminary results anticipated during the second half of 2009.

The PROSPECT II study is a prospective, double-blinded, sham-controlled study designed to build on the positive safety profile and promising efficacy observed in...

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