P.A.P. Orthosis Cranial Remolding in Utah
In early 1997, Fit-Well began the process of preparing for F.D.A. clearance. There were many hurdles to overcome in order to be cleared by the F.D.A., such as providing results that the proprietary transparent thermoplastic material used to manufacture the P.A.P. was safe and would not cause any reaction when used next to the skin. Also proving the safety and effectiveness to the patient and that the P.A.P. actually corrects the misshaped cranium of infants. There were 195 infant cases that provided the information regarding the safety and effectiveness of the P.A.P. Orthosis, which began the F.D.A. process. As of January 2002, Fit-Well received the Food and Drug Administration clearance for the P.A.P. Orthosis. (Plagiocephalic Applied Pressure Orthosis)
Unique advantages of using the P.A.P. Orthosis
Transparent material allows the skin to be seen through the material facilitating visual inspection by the parents or caregiver. The visual inspection helps prevent skin breakdown, irritation, and possible sores. The material is more flexible than the traditional plastics used, which aids in suspension of the device upon the infant’s head, is less bulky, and also allows for growth modifications as the infant’s head develops. The P.A.P. Orthosis can either be active or passive in design. The P.A.P. weighs approximately 5-6 oz, and is available to treat plagiocephalic, brachycephalic and scaphocephalic shaped heads. Positional plagiocephaly is the development of an abnormal shaped head. Fit-Well has had tremendous success with the methods of fitting, manufacturing and patient follow-up, all coming together to produce a fast, safe, and enjoyable treatment program. Fit-Well is currently seeking patent protection for the methods used to create the P.A.P. Orthosis.
Effectiveness of Conservative Therapy and Helmet Therapy for Positional Cranial Deformation
The prevalence of deformational plagiocephaly and deformational brachycephaly has increased significantly since the adoption of the Back to Sleep campaign in 1992. Although the rate of sudden infant death syndrome has decreased by as much as 40 percent, the incidence of positional cranial deformation is estimated to have increased by as much as 600 percent, with a significant increase in the number of case referrals to specialized treatment centers. Current prevalence estimates of positional cranial deformities are as high as 47 to 48 percent.