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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 includes either a reusable delivery "gun" or a disposable
syringe and an assortment of applicator tips (standard
tips, 12mm and 16mm spreader tips, and 10cm and 27cm extender
tips). 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 clotting
cascade. The delivery device-mediated application is |
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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
 Launched in May 2004 (2mL and 5mL) in the U.S. and Europe and in
November 2004 in Canada, CryoLife BioGlue Syringe is
a self-contained, easy-to-use, disposable delivery system
for BioGlue Surgical Adhesive.
The pre-filled device is available in 2mL, 5mL,
and 10 mL (launched December 2005 in Europe and March
2006 in the U.S. and Canada) 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.
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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 can distribute BioGlue in more
than 60 countries worldwide including the United States,
Canada, Australia, European Union, and several countries
in 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 and
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.
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