CryoLife said 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.
BioGlue Surgical Adhesive is 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.
Further, BioGlue is approved in Canada for use in soft tissue repair and in Australia for use in vascular and pulmonary sealing and repair.
BioGlue received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in the repair of aortic dissections in September 2010.
Prior to distribution, MHLW completed a remote inspection of CryoLife pursuant to Japanese Quality Management System requirements and required product reimbursement paperwork for Japanese authorities.
CryoLife’s partner Century Medical Inc (CMI) will distribute BioGlue in Japan for use in this subset of cardiac surgery.
CryoLife will remain the exclusive supplier of BioGlue to CMI.
