Carolina Kinder Development uses the direct plaster cast molding technique followed by a custom fabrication process for cranial banding. The molding step provides the initial head shape information, and the fabrication process produces the corrective band that will support growth into the new symmetrical head shape dimensions.
We consider direct casting to be the gold standard for measurement and to offer the most safe and reliable outcome for each infant. The accuracy of alternative technologies (such as laser scanning and digitizing) is always judged based upon a comparison with the direct cast molding and fabrication technique. Obtaining an accurate mold is relatively skill intensive compared to newer high-throughput technologies. In the hands of skilled and experienced professionals, molding is very well-tolerated by infants, comparable to scanning and digitizing. CSO and Carolina Kinder Therapy continue to use the direct casting technique for 2 reasons:
- It is highly accurate. Be it bony nuances or a moving infant, these do not diminish the accuracy when casting is done by a highly trained clinician.
- It has a long history of safety for infants and does not rely on more recent technologies with less historical data.
The fabrication step is done at CSO in New Jersey, where the specially shaped band is produced. This band corrects the current head shape of the child as he or she grows during a period of 6 to 16 weeks. The cranial orthotic band is an FDA Class II medical device, which requires any manufacturer to be 501(k) compliant. Our manufacturer, Cranial Solutions, is fully 501(k) compliant and FDA approved.
OUR SPECIALIZED CARE:
We are partnered with Cranial Solutions (CSO) in New Jersey, which is exclusively devoted to cranial orthotics and has over 20 years experience in the manufacture of cranial orthotic devices. The cranial orthotic band is an FDA Class II medical device, which requires any manufacturer to be 501(k) compliant. The combined operation is fully 501(k) compliant and FDA approved.
By drawing on our combined skills and experience, Carolina Kinder Development in partnership with CSO brings the most rigorous standards of competency achieved through years of practice and intensive continuing education. Because we are a small dedicated laboratory, we can offer personalized and supportive care, understanding the unique needs presented by each of our patients. This means consistently excellent results and positive change for each individual child.
Please contact Carolina Kinder Development with questions or to make an appointment.