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Cranial Solutions Orthosis (CSO)
The CSO is Approved by the Food and Drug Administration for its intended use on infants from three to eighteen months of age with moderate to severe non-synostic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and/or shape.
The CSO is of thermoplastic construct consisting of a semi-rigid outer shell of Orthopedic grade copolymer polypropylene thermobonded to a medium durometer polyethylene foam inner lining of Volara®. The FDA has also tested and approved this Volara® inner lining for long term skin contact. By design the CSO is a dynamic device (a device that applies a low energy load to constrain and correct abnormal growth) that has a single lateral opening on the side adjacent to the flattened occipital-parieto region and an opening on top for excellent air flow. The CSO is very light in weight and can bench test in as little as 4.6 ounces. The Cranial Solutions Orthosis is easy to apply and remove by parent or care giver. The standard treatment time is three months with biweekly follow-up appointments for anthropometric measurement evaluation, normal growth adjustments, and progress reports.
The CSO is NOT intended for infants with craniosynostosis or hydrocephalus.
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