Thursday, December 21, 2006
Cool-Cap System Gets FDA Nod
Filed under: Critical Care
, Pediatrics
This is a device we covered a while back, when it was in the embryonic stage of development. Now it's ready to graduate into NICUs across the country, thanks to an FDA approval:
The Food and Drug Administration (FDA) today [December 20, 2006 --ed.] 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 of Seattle, WA."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...
The Olympic Cool-Cap system, explained by the company:
Control SystemAll operator controls and displays are on the touch screen. This eliminates mechanical buttons and a separate keyboard, and it enables the clinician to enter commands and notes while viewing patient data. Critical patient data is displayed in larger, color coded numbers for easy reading. The software program guides the physician and staff through the cooling protocol from start to finish...
Cooling Unit
A solid-state water cooler (not a refrigerator compressor) is used for more rapid and precise temperature control. Temperature response is 0.1° C. The solid-state cooler is also very reliable and quiet. Water flow rate and pressure are accurately maintained for all size caps. Filling and draining the cooling unit is simple and fast. The cooling unit is fill by connecting it to any readily available one-litre bag of sterile water. At the end of the treatment, the water is drained back into the bag for disposal. No internal cleaning of the cooling unit is required after use, except for periodic maintenance.
The Cooling Cap
The cooling cap itself was designed for the clinical trial and incorporates refinements based on experience during the trial. It consists of a water recirculating cap next to the infant's skin which is covered by an insulated outer cap. The cap provides uniform and controlled cooling of the critical region of the head. The inner cap has a network of channels that recirculate water from the cooling unit for efficient and controlled heat transfer. The pattern of the water channels provides maximum and uniform cooling contact with the head and prevents pressure points. To help maintain the desired cap cooling temperature, the outer cap is insulated and is covered with reflective metal foil to minimize heating caused by the radiant warmer. The disposable cooling cap is furnished in three sizes.
FDA press release...
Olympic Medical website...
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