Medical Device Daily

The FDA approved a first-of-a-kind medical device last week 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 during delivery.

The Olympic Cool-Cap system is designed to prevent or reduce damage to the brains of infants younger than 36 weeks by keeping the head cool while the body is maintained at a slightly below-normal temperature. The Cool-Cap is made by Olympic Medical (Seattle), which was acquired by Natus Medical (San Carlos, California) in October for about $19.3 million (Medical Device Daily, Oct. 17, 2006).

Steven Murphy, CFO of Natus, told Medical Device Daily that Olympic Cool-Cap studies started in 1999.

“What’s great about it is Olympic was a small closely-held company and they just took it upon themselves to do all the PMA work which is a little unusual ... so we are really glad they did,” Natus said.

When Natus acquired Olympic two months ago it was still uncertain if the FDA would approve the device, Murphy said.

“Certainly the market opportunity is well over $100 million. I think the only question is how quickly the clinical community will begin accepting this technology and using it. From all indications so far it will become a standard of care as long as the patient meets the criteria,” Murphy said.

The 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, the company 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.

“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 Daniel Schultz, MD, director of the agency’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% of them died, and 25% suffered permanent disability because of neurological deficits.”

About 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, according to Natus. In 1999, Olympic Medical initiated a four-year international multi-center study of the Cool-Cap system. Results of the study confirmed that when head cooling therapy was administered to patients within the first six hours of life, thereby lowering the body temperature three to four degrees Centigrade, the severity of brain injury was significantly decreased compared to the untreated control group. 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.

“Until now, there has been no FDA-approved way to improve life for these babies,” said John Barks, MD, associate professor of pediatrics and director of the neonatal-perinatal research programs at the University of Michigan (Ann Arbor). “Now cooling the brain lets us offer hope to parents. Most parents quickly grasp the concept underlying cooling and are ready to accept the therapy for their child. I use the analogy of icing an injured joint. As a cooling referral center, we have three Cool-Caps, because on more than one occasion we have had to simultaneously treat two babies and also needed a back-up.”

Natus plans to market the Cool-Cap system to Level III neonatal intensive care departments worldwide, with each center using two Cool-Cap devices. Based on these metrics, Natus anticipates a market potential of more than 4,000 devices worldwide.

Olympic Medical also developed the CFM 6000 Cerebral Function Monitor and received FDA 510(k) clearance to market the product in 2003. The CFM 6000 is used in the Neonatal Intensive Care Unit and other acute care departments to perform continuous, long-term monitoring of a newborn’s brain activity. The CFM 6000 monitor enables clinical staff to assess the function of the brain as an aid to both diagnosis and treatment of a variety of neurological conditions such as seizures, HIE, and the effects of medication.

“Natus once again is leading the market by providing customers with products that deliver significant benefits,” said Jim Hawkins, president/CEO of Natus. “We clearly were the leader in developing newborn hearing screening into a standard of care, and we expect to leverage that experience as we now look to make routine brain monitoring and head-cooling of newborns a new standard of care.”

Natus provides healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical ailments such as hearing impairment, neurological dysfunction, epilepsy, sleep disorders, newborn jaundice, and newborn metabolic testing.