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 that consists of either a reusable delivery device and disposable syringe or a disposable syringe and an assortment of applicator tips (standard tips, 12mm and 16mm spreader tips, and 10cm and 27cm extender tips).

The adhesive solutions are mixed in a predefined ratio within 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 independent of the body's clotting cascade.

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.

BioGlue Syringe

CryoLife's BioGlue Syringe is a self-contained, easy-to-use, disposable delivery system.  The pre-filled device is available in 2mL, 5mL, and 10 mL volumes and is fully disposable.

The all-inclusive packaging saves time and space and the design of the syringe increases site access and visualization of the target site.  "Clinical and hospital staffs are pleased with its precise delivery of BioGlue," said Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc.  "Since its introduction in the U.S. in December 2001, BioGlue has seen a significant increase in acceptance and usage by surgeons as an integral part of their surgical practice."

Approvals

CryoLife currently distributes BioGlue to more than 60 countries worldwide including the United States, Canada, Australia, European Union, and several countries within Latin America and Asia.

FDA Approval
BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral and carotid arteries).

CE Mark Approval
BioGlue is indicated for use as an adjunct to standard methods of surgical repair (such as sutures, staples, electrocautery, and/or patches) to bond, seal, and/or reinforce soft tissue.  BioGlue may also be applied alone to seal and/or reinforce damaged parenchyma when other ligature or conventional procedures are ineffective or impractical.  Indicated soft tissues are cardiac, vascular, pulmonary, genitourinary, dural, alimentary (esophageal, gastrointestinal, and colorectal), and other abdominal (pancreatic, splenic, hepatic, biliary).  Additionally, BioGlue is used in the fixation of surgical meshes in hernia repair.