Search Results

The P-POD Plagiocephaly Orthosis Device is intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The Lorica Scientific LLC P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner. The Lorica Scientific LLC P-POD Plagiocephaly Helmet differs from the predicate devices in that the device is made in the physician's office via a simplified casting process that can be performed in approximately 30 minutes. The predicate devices rely on a 2 to 4 week process of sending the child for a 3-D scan and then using casting and molding processes to create a customized helmet. The P-POD standardized (2 sizes) helmet consists of a hard outer shell with an inflatable bladder lining the inside. Modeling putty is used to fill in the flattened portion of the infants head to form the desired symmetrical shape and the helmet is placed on the infant. The physician then mixes a pre-measured solution in an easy-to-use, pre-measured pouch and pours the mixed solution into the bladder of the helmet through a specially designed filling port located at the top of the helmet. As the chemical solution cures, there is an exothermic foaming process from a liquid to solid foam which expands to fill the empty space in the bladder thus customizing the helmet to the shape making a negative copy of the infant's skull. Since the putty is used to fill in the undesired negative regions of the skull deformity, once the foam is completely cured and putty removed, the resulting helmet provides an ideal cast to help promote proper skull re-contouring. As with all other similar cranial orthosis devices, as the infant wears the helmet, the head grows into the shape formed by the foam, thereby correcting the deformity.