February 18, 2008 – Last week Natus Medical said the FDA cleared its supplement to the premarket approval application for the Olympic Cool-Cap, a head-cooling device to prevent or reduce the severity of neurologic injury associated with hypoxic ischemic encephalopathy (HIE) in term newborns.
Approximately three in 1,000 newborns are at risk of brain injury due to an interruption of blood flow and oxygen supply during labor and delivery. In 1999, the company’s Olympic Medical division initiated a four-year international multi-center study of the Cool-Cap system. Results of the study showed when head-cooling therapy was administered to patients within the first six hours of life, the severity of brain injury was significantly decreased compared to the untreated control group. The company said the study enrolled babies at high risk for moderate to severe brain injury as diagnosed by using the company’s Olympic CFM 6000 Cerebral Function Monitor, which aids in identifying neurological abnormalities such as HIE.
In December 2006, Natus announced it received premarket approval from the FDA to market the Cool-Cap, a Class III medical device. In transitioning production of the Cool-Cap from clinical units to commercial units, the company updated many of its components, requiring the company to submit a premarket approval supplement to the FDA. The company had previously put a hold on domestic shipments of Cool-Cap units, but resumed them again last week, following the FDA’s supplement approval Feb. 11.
For more information: www.natus.com