P.A.P Orthosis (Plagiocephalic Applied Pressure Orthosis)
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 miss-shaped 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 are:
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.