BioGlue: albumin/glutaraldehyde sealant in cardiac surgery.

BioGlue is a commercially available sealant manufactured by Cryolife (Atlanta, GA) as a hemostatic adjunct for cardiac and vascular surgery. This type of sealant has evolved conceptually from the gelatin resorcinol formalin glue (GRF or "French Glue") in the sense that it is devised not only to act a sealant but also as an agent to strengthen friable tissues, particularly in acute aortic dissection. In fact, the initial availability of BioGlue in the United States was under an FDA humanitarian device exemption for use in acute aortic dissection. This novel regulatory strategy expedited clinical use of BioGlue in acute aortic dissection and was permissible because of the small number of patients (less than 4000 per annum) in the potential treatment population. In this article, we will discuss the mechanism of action and composition of this agent, preclinical experience, the results of a prospective randomized trial as well as the results of our initial experience with BioGlue at MGH.