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Northstar’s Neurostimulation For Recovering Stroke Victims Still Years Away

This article was originally published in The Gray Sheet

Executive Summary

Northstar NeuroScience aims to submit its Northstar Stroke Recovery System for FDA's consideration by the first quarter of 2008, according to VP John Bowers

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Northstar Neuroscience

Seattle firm announces completion of enrollment May 31 in the 174-patient, 21-center randomized pivotal trial of its Renova-ST cortical stimulation system for treatment of post-stroke motor recovery. The EVEREST trial compares improvement in hand and arm function in chronic stroke survivors treated with physical therapy alone versus those treated with physical therapy plus stimulation of the cerebral cortex with Renova-ST. Northstar hopes to file a PMA for the device by the end of 2007 (1"The Gray Sheet" July 31, 2006, p. 13)...

Northstar Neuroscience

Seattle firm announces completion of enrollment May 31 in the 174-patient, 21-center randomized pivotal trial of its Renova-ST cortical stimulation system for treatment of post-stroke motor recovery. The EVEREST trial compares improvement in hand and arm function in chronic stroke survivors treated with physical therapy alone versus those treated with physical therapy plus stimulation of the cerebral cortex with Renova-ST. Northstar hopes to file a PMA for the device by the end of 2007 (1"The Gray Sheet" July 31, 2006, p. 13)...

Northstar neurostim depression study

Northstar Neuroscience is enrolling patients in a cortical stimulation feasibility study for treatment-resistant depression following FDA go-ahead in August. At the Leerink Swann stroke devices roundtable in New York Oct. 4, CEO Alan Levy said the firm is motivated by the large market size for depression. The PROSPECT trial will enroll up to 12 patients at three sites. Northstar's implantable technology stimulates the outermost layer of the brain, the cortex, to encourage brain activity. According to the firm it is less invasive than other, deeper brain stimulations. Levy projects a 2008 PMA filing for the Northstar Stroke Recovery System for hand and arm rehabilitation in stroke victims (1"The Gray Sheet" July 31, 2006, p. 13)...

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