BioFoam® Surgical Matrix

biofoam_applicator

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.

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In the US, BioFoam is approved for investigational use only.