ROCKVILLE, Md., Dec. 20 -- The FDA today approved Olympic Cool-Cap, a device that cools the head to prevent damage caused by neonatal hypoxic-ischemic encephalopathy (HIE), a condition that affects 5,000 to 9,000 newborns each year.
The agency said Cool-Cap was indicated for treatment of moderate to severe HIE. The device keeps the head cool while the body is maintained at a slightly below-normal temperature.
In making the announcement, Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said until now HIE treatment was limited to supportive care.
He said historically about 20% of HIE babies died and another 25% suffered permanent disability because of neurological deficits.
The Olympic Cool-Cap treats the patient by maintaining a steady flow of water at a selected cool temperature through a cap covering the infant's head.
The system, which consists of a cooling unit, a control unit, temperature probes and a water-filled cap, was found safe and effective in a study with 234 infants with moderate to severe HIE. At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group compared with the control group.
As a condition of the approval, Olympic Medical Corporation of Seattle, maker of the device, will set up a patient registry to collect information on device usage and to track treatment outcomes.
The company will also organize a training and certification process for all operators of the device.
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