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Guidant Neurolink

This article was originally published in The Gray Sheet

Executive Summary

Humanitarian device exemption approval of the intracranial stent system covers use for recurrent intracranial stroke due to atherosclerotic disease refractory to medical therapy in vessels 2.5 to 4.5 mm in diameter with greater than 50% stenosis. Post-approval requirements include collection of 12-month follow-up data...
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