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BioGlue® Surgical Adhesive

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CRYOLIFE, INC.

1655 Roberts Boulevard, NW
Kennesaw,  Georgia   30144
United States


800-438-8285
770-426-0031 FAX
888-427-9654 CUSTOMER SERVICE

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BioGlue Overview
BioGlue Surgical Adhesive is a flexible, protein hydrogel that covalently crosslinks with tissue and mechanically binds with synthetic materials for optimal strength and adherence. BioGlue polymerizes in 20–30 seconds and reaches full strength in 2 minutes. The simple syringe delivery system allows for direct and easy applications for sealing, adhering, and reinforcing tissues.

The BioGlue Advantage

Safe
Clinically proven in more than 500,000 cases worldwide since 1998.
  • Over 250 published preclinical and clinical papers discussing safety, efficacy, and application techniques.
  • Remains a flexible and pliable hydrogel (~63% water) following implantation.
  • Biocompatible and biodegradable.

Simple
Simple, ergonomic design allows for unmatched preparation and ease of use.
  • Off-the-shelf and ready for use in just seconds.
  • Room temperature storage eliminates the need for thawing.
  • Absolutely no manual mixing required.

Effective
Unprecedented strength and versatility allow for use in even the most complex cardiovascular procedures.
  • Seals anastomotic suture lines ranging from peripheral vascular repairs to ascending aortic reconstructions.
  • Adheres tissues together in complex aortic dissection situations.
  • Reinforces friable tissues in difficult cardiovascular procedures.
Keys to Success

    1. DRY the target site.
    2. PRIME the applicator tip.
    3. APPLY BioGlue in a slow and steady manner.
    4. APPLY in thin, even layers.
    5. WAIT two minutes for full strength.

Syringe Delivery System

  • Pre-filled, fully disposable syringes available in 10mL, 5mL, and 2mL volumes.
  • All inclusive packaging saves time and space.

How It Works
The method of application is designed to provide reproducible mixing of the components in vitro. The crosslinker covalently bonds the bovine serum albumin 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 mechanism. BioGlue also adheres to synthetic graft materials via mechanical interlocks within the interstices of the graft matrix.

Rapid Polymerization

After mixing, the polymerization begins immediately and the two components are consumed as the amines and aldehydes are linked together. Only enough aldehyde groups remain to bind the BSA to the target site.

BioGlue Properties
BioGlue is a hydrogel that will remain pliable and flexible as long as it is kept in a hydrated environment (i.e., inside the human body).
Approvals
CryoLife has approvals to 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.


Professor Westaby White Paper: Surgical Strategies in Acute Type A Dissection

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