FDA Clears Baxter Fibrin Sealant Applicator
Tisseel VH fibrin sealant, the first fibrin sealant to receive FDA approval, is indicated as an adjunct to blood clotting in surgeries involving cardiopulmonary bypass and repair of the spleen. It can also be used for colostomy closure.
The sealant contains fibrinogen and thrombin, two components that occur naturally in blood. When combined, these components form fibrin, the essential part of a blood clot. Fibrin establishes a mesh-like structure that holds platelets, small particles in the blood that contribute to the clotting process, and additional fibrin that forms at the site of bleeding.
When applied via the Tissomat application device and Spray Set device, the two components of Tisseel VH fibrin sealant are passed through separate outlets in the spray head, and then mixed and atomized by means of pressurized gas. The result is a thin layer of fibrin sealant which can cover approximately 200 squared cm. Existing applicators consist of a cannula, a small tube, which can deliver the fibrin sealant to an area of approximately 16 squared cm.
The Hyland Immuno division of Baxter develops and produces therapeutic proteins from plasma and through recombinant methods to treat hemophilia, immune deficiencies and other blood-related disorders. Hyland Immuno's portfolio of therapies includes coagulation factors, immune globulins, albumin, wound management products, and vaccines.