The US Food and Drug Administration has just approved a new 10 ml disposable syringe for BioGlue Surgical Adhesive, with new expanded use of BioGlue system for cardiovascular and other large vessel surgeries. The novel delivery system is touted to provide clinicians with a product that “improves surgical site access, visualization, and control.” In addition, a syringe spreader tip is now available that allows for easier application of BioGlue in a thin even layer.
Here’s how the BioGlue works:
BioGlue® Surgical Adhesive (BioGlue) is a two-component surgical adhesive composed of purified bovine serum albumin (BSA) and glutaraldehyde. The solutions are dispensed by a controlled delivery system, composed of a reusable delivery device, applicator tips, and applicator tip extenders. Once dispensed, the adhesive solutions are mixed in a predefined ratio in the applicator tip where cross-linking begins. The glutaraldehyde molecules covalently bond (cross-link) the BSA molecules to each other and, upon application, to the tissue proteins at the repair site, creating a flexible mechanical seal independently of the body’s clotting mechanism. The delivery device-mediated application is designed to provide reproducible mixing of the components in vitro. BioGlue begins to polymerize within 20 to 30 seconds and reaches its bonding strength within 2 minutes. BioGlue also adheres to synthetic graft materials via mechanical interlocks within the interstices of the graft matrix. The BioGlue component has a shelf life of 3 years if stored at 25° C.