AirXpanders, a medical device company focused on the design, manufacture, sale and distribution of the AeroForm Tissue Expander System, announced that the company has submitted a Special 510(k) pre-market notification to the US Food and Drug Administration (FDA) for a Smooth Shell version of the AeroForm Tissue Expander System.
The purpose of the Special 510(k) pre-market notification is to request US FDA clearance for commercial use and distribution of a smooth, untextured version of the AeroForm Tissue Expander System for use in soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast.
The AeroForm Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
“Following in the wake of our successful launch of the AeroForm Tissue Expander System, we are excited to bring a smooth version to market.” said Frank Grillo, President and CEO of AirXpanders.
“The Plastic Surgery community has embraced the textured version of our tissue expander, and they have also been asking us to provide a smooth, untextured version of AeroForm. We are looking forward to introducing our smooth expanders and offering our unique products in both smooth and textured versions.”
Later this year, AirXpanders also plans to file a Regulatory submission with the Australian Regulatory body, the Therapeutic Goods Administration (TGA), requesting approval of the smooth shell AeroForm Tissue Expander.
Source: Company Press Release