CryoLife Inc, a human tissue processing and surgical device company, announced the CE mark approval for distribution in the European Union of a new disposable delivery system for BioGlue Surgical Adhesive.

The new BioGlue Syringe is expected to provide clinicians with improved convenience and ease of use. On Monday, May 17, 2004, the company announced the FDA approval of the same delivery system for distribution in the United States.

"Since its introduction in Europe in 1998, BioGlue has seen a significant increase in acceptance and usage by surgeons as an integral part of their surgical practice," said Steven G. Anderson, president and chief executive officer, CryoLife, Inc. "International BioGlue sales increased 24 per cent in the first quarter 2004 compared to the same period in 2003. Twenty percent of total BioGlue revenues are derived from outside the United States."

The BioGlue Syringe provides surgeons with an effective adhesive in an easier-to-use, self-contained, disposable syringe. The BioGlue Syringe will be available in 2ml and 5ml volumes. Since its introduction in 1998, CryoLife has distributed over 225,000 units of BioGlue worldwide.

BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body's clotting mechanism, within 20 to 30 seconds and reaches its maximum bonding strength in two to three minutes.

The company's BioGlue Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE marked in the European Community and approved in Canada for use in soft tissue repair and approved in Australia for use in vascular and pulmonary sealing and repair.