Olympic Cool-Cap System: Novel Device That Prevents/Reduces Brain Damage in Infants, USFDA Approved

Filed in archive Diagnostics , Treatment on January 2, 2007

A first-of-a-kind medical device for the treatment of babies born with moderate to severe hypoxic-ischemic encephalopathy (HIE), has just been approved by the USFDA.

HIE (hypoxic-ischemic encephalopathy) is a potentially fatal injury to the brain caused by low levels of oxygen.

The said device, manufactured by Olympic Medical Corporation (a subsidiary of San Carlos, California-based Natus Medical Incorporated) - called The Olympic Cool-Cap System (pdf file) - 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.

According to Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health:

"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.

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."

Find more details from FDA News.