Numerous variants of fibrin sealant exist, including autologous products. Other sealants include those containing thrombin, collagen & gelatin-based ingredients.
Fibrin sealants are used in the U.S. in a wide array of applications; they are used the most in orthopedic surgeries, where the penetration rate is stands at 25-30% of such procedures. Fibrin sealants can, however, be ineffective under wet surgical conditions. The penetration rate in other surgeries is estimated to be about 10-15%.
Fibrin-based sealants were originally made with bovine components. These components were judged to increase the risk of developing bovine spongiform encephalopathy (BSE), so second-generation commercial fibrin sealants (CSF) avoided bovine-derived materials. The antifibrinolytic tranexamic acid (TXA) was used instead of bovine aprotinin. Later, the TXA was removed, again due to safety issues. Today, Ethicon’s (JNJ) Evicel is an example of this product, which Ethicon says is the only all human, aprotinin free, fibrin sealant indicated for general hemostasis. Market growth in the Sealants sector is driven by the need for improved biocompatibility and stronger sealing ability—in other words, meeting the still-unsatisfied needs of physician end-users.
Source: MedMarket Diligence, LLC; Report #S290.