FDA APPROVES DEVICE TO PREVENT OR REDUCE BRAIN DAMAGE IN INFANTS

The FDA Dec. 20 approved a first-of-its-kind device to treat 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 agency said. The Cool-Cap is manufactured by Olympic Medical.

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.

Prior to the approval, there was no effective treatment for the approximately 5,000-9,000 babies suffering from HIE other than supportive care, CDRH Director Daniel Schultz said. "Up to 20 percent of them died, and 25 percent suffered permanent disability because of neurological deficits."