One of the concerns a parent has for their newborn is having to be mindful of prolonged contact pressure around the baby’s scalp while he or she has yet to develop a hardened skull, as well as having the ability to support head and neck movements. Normally, parents have to periodically turn the infant’s head to rest on different sides to avoid skin irritation and deformational plagiocephaly (DP), a cranial deformity. Fortunately, San Antonio-based medical device company Invictus Medical appears to have come up with a novel solution through a new medical device.
The company, in keeping with their commitment to the healthy development of infants and children, has just filed an application to the US Food and Drug Administration for a device indicated for the relief of newborn babies’ extracranial pressure due of prolonged immobility.
Incidences of DP have been on the rise since the 1990s. Aside from being a cosmetic concern, a study published last year in the journal Pediatrics showed that it may be a factor in pediatric developmental delays.
This application, also referred to as a 510(k) document, is the last requirement before being granted regulatory approval and marketing clearance. To support their application, Invictus included the results of a safety study conducted in a hospital in Dallas, Texas. The U.S. Patent and Trademark Office has already approved of the brand name GelShield™ for use upon FDA clearance. According to Invictus President and CEO Tom Roberts, the company expects to launch the product early 2015.
Invictus describes the GelShield as “a thin, flexible, fiber-material head wrap” with a soft, cotton poly-blend inner lining that covers a flexible plastic gel pack core. The materials combine to offer a preventative option for significantly reducing cranial complications, including pressure ulcers, and greatly reduces peak pressure.
BioNews Texas reports on a wide variety of emerging medical devices developed in the Texas biotech industry. A particularly interesting device is Spot On Science’s HemaSpot, which uses a fingerstick to collect blood samples remotely, then employs the same dried blood spot (DBS) technology used in newborn screening. This stabilizes the blood sample for transit to a laboratory.