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FDA Panel Backs Safety Of Infant Cooling Cap To Avert Brain Damage

This article was originally published in The Gray Sheet

Executive Summary

Olympic Medical should maintain a post-approval registry to identify a more distinct treatment population to receive the firm's Cool-Cap hypoxic-ischemic encephalopathy (HIE) device, according to FDA's Neurological Devices Panel

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Hypothermia Therapy Is No Help To Children With Brain Trauma

Controlled hypothermia is not effective in treating children with traumatic brain injury and might even contribute to worsened outcomes, according to a study published June 5 in the New England Journal of Medicine

Olympic Cool-Cap approval

FDA approves Olympic Medical's Olympic Cool-Cap device to treat hypoxic ischemic encephalopathy in term newborns on Dec. 20. Roughly three in every 1,000 newborns are at risk of brain injury due to an interruption of blood flow and oxygen supply during labor and delivery. The device, administered within the first six hours of life, lowers body temperature 3-4 ?C to reduce brain swelling. FDA's Neurological Devices Panel voted 5-1 in favor of approval in June 2005 (1"The Gray Sheet" June 20, 2005, p. 9). As conditions of the approval, Olympic will set up a patient registry to collect information on device usage and to track treatment outcomes; organize a training and certification process for device operators; and restrict use of the device to patients who meet the eligibility criteria defined by the original study. Seattle-based Olympic, a subsidiary of Natus Medical, will market Cool-Cap via its own sales and distribution team...

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