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.
BioFoam has received CE Mark certification, which permits its sale within the European Economic Area (EEA). BioFoam’s CE Mark certification is for the following indication:
“…for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or conventional methods is ineffective or impractical.”
The US Food and Drug Administration (FDA) has granted CryoLife an Investigational Device Exemption (IDE) which permits BioFoam Surgical Matrix to be used in a clinical study in the United States of America to determine its safety and effectiveness in sealing liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.