FDAnews
www.fdanews.com/articles/72088-northstar-announces-everest-study-for-survivors-of-stroke

Northstar Announces EVEREST Study for Survivors of Stroke

May 9, 2005

Northstar Neuroscience, a privately held developer of medical devices for the treatment of neurological diseases and disorders, announced that the FDA has granted approval for a pivotal clinical study of its investigational cortical stimulation system to enhance the recovery of hand/arm function following stroke. The EVEREST study is a randomized, multicenter study comparing the effects of cortical stimulation plus rehabilitation to rehabilitation alone. The company intends to use data from EVEREST to support a future submission for premarket approval in the U.S. The clinical study is currently enrolling patients at a number of U.S. medical centers under a previous conditional FDA approval, and the company will now proceed with study initiation at a larger number of clinical sites.

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