| BioFoam® Surgical Matrix |
|
BioFoam is a proprietary CryoLife developed product that contains a protein hydrogel biomaterial with an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. BioFoam has been demonstrated to be a minimal activator of the intrinsic coagulation pathway. The product characteristics associated with clinical effectiveness include the adherence of the product to the surface of the tissue (cross-linking) and expansion of the product. BioFoam is provided in a double-barreled container that is prefilled with solutions of protein and a cross-linker. Upon mixing of the two solutions in the applicator tip attached to the container, both the foaming and cross-linking reactions begin. The foamy liquid expelled from the tip is adhesive, but sets up within seconds as soft foam.
|



These solutions are filled into the barrels of the container at a 4:1 volume ratio, respectively, packaged into an inner foil pouch and an outer Tyvek® pouch, and terminally sterilized by gamma-irradiation. The material is expelled by advancing the pistons within the barrels of the container utilizing a manual plunger.