ORTHOMERICA PRODUCTS, INC. 704.08PA St. Louis Band

The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.