
Ottowa-based Canica Design Inc. landed pre-market approval from the FDA for its DynaCleft device, a pre-surgical treatment for cleft lip/palate.
The DynaCleft is a cleft lip and palate treatment that uses an elastomeric band to bridge the cleft segments. The device slowly guides soft tissues and bone of the cleft lip and palate into a better position for repair, making the cleft repair surgery easier for both surgeon and baby.
A recent study in the Cleft Palate-Craniofacial Journal found the device to be the equal of the naso-alveolar molding intra-oral appliance, the common pre-surgery treatment option for a cleft lip/palate, according to a press release.
“If I was an infant with complete unilateral cleft lip and palate, and soon after my birth someone would place an appliance inside my mouth, a nasal antenna which would obstruct my nasal passage, and cover around my mouth with paper tape, I would certainly not be a happy baby,” the study’s lead author Dr. Luis Monasterio said, in prepared remarks.