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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Approves Novel Device That Prevents or Reduces Brain Damage in Infants
The Food and Drug Administration (FDA) today approved a first-of-a-kind medical device for the treatment of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE), a potentially fatal injury to the brain caused by low levels of oxygen. The Olympic Cool-Cap system is designed to prevent or reduce damage to the brains of these patients by keeping the head cool while the body is maintained at a slightly below-normal temperature. The Cool-Cap is manufactured by Olympic Medical Corporation, a subsidiary of Natus Medical Incorporated of San Carlos, Calif.
“This approval brings new hope to parents of the approximately 5,000-9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy,” said Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health. “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.”
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 conditions of the approval, Olympic Medical Corporation will set up a patient registry to collect information on device usage and to track treatment outcomes; organize a training and certification process for all operators of the device; and restrict use of the device to patients who meet the eligibility criteria defined by the original study.