THURSDAY, Dec. 21 (HealthDay News) -- The U.S. Food and Drug Administration has approved the Cool-Cap system (Olympic Medical Corp., Seattle), a unique medical device that cools head temperature to prevent or reduce damage in infants with moderate to severe hypoxic-ischemic encephalopathy. Until now, the condition, which kills 20 percent and leaves 25 percent with permanent disability, could only be treated with supportive care.
The system consists of a water-filled cap, temperature probes and cooling and control units, and cools the infant's head with a steady flow of chilled water circulated through the cap. Body temperature is maintained at slightly below-normal temperature. A study of 234 infants with moderate to severe hypoxic-ischemic encephalopathy found less mortality and fewer severe cases of neurodevelopmental disability in the treated group compared with controls.
Olympic Medical Corporation will set up a patient registry to gather device usage data and to track outcomes, will organize training and certification for device operators, and must restrict the device only to patients meeting the original study's eligibility criteria.
"This approval brings new hope to parents of the approximately 5,000 to 9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, in a statement. "Until now, there has been no effective treatment for these infants other than supportive care. Up to 20 percent of them died and 25 percent suffered permanent disability because of neurological deficits."
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