The Neurological Devices Panel (the Panel) met on Friday, June 17, 2005 in Gaithersburg, MD to make a recommendation to the Food and Drug Administration (FDA) on the approvability of Olympic Medical Corporation PMA, P040025 for the Cool-Cap® selective head cooling system intended for use in infants 36 weeks of gestation or older at risk for moderate to severe hypoxic ischemic encephalopathy (HIE) to prevent or reduce the severity of HIE.
The Panel membership for this meeting consisted of a neurosurgeon, two neurologists, an interventional neurological radiologist, a statistician, two neonatologists, a pediatric intensivist, a consumer representative, and an industry representative.
Family members of three Cool-Cap® treated patients spoke of their experience with the device and recommended approval of the device. The sponsor and the FDA presented their summaries of the data in the PMA. A Panel member, a neonatologist, then gave his perspective on the PMA data. After deliberations on the data in the submission, the Panel considered FDA’s questions.
The Panel then voted five to one with one abstention to recommend that FDA approve the PMA with conditions. The recommended conditions of approval are as follows:
- A registry should be instituted to collect information on real world device usage to track patient outcomes,
- A training and certification process should be required for all users of the device, and
- Use of the device should be restricted to the protocol defined patient population.
The Panel member who voted against approval with conditions stated that the study did not demonstrate statistical differences between the treatment and control groups.
The Panel member who abstained from voting stated that he was impressed that the sponsor had conducted a controlled trial, but had concerns about the ability of data from the study to show effectiveness.
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