CryoLife Inc announced that Health Canada, the state ministry that oversees Canadian healthcare, has significantly expanded its approved indications for BioGlue surgical adhesive.
BioGlue, a surgical adhesive developed by CryoLife, was initially approved in Canada in January 2000 for use in cardiac and pulmonary soft tissue repair. The new indications allow BioGlue to be used as an adjunct method to repair most human soft tissue.
"This latest approval will permit BioGlue's use in Canada in most soft tissue surgical procedures throughout the human body," said Steven G. Anderson, President and Chief Executive Officer of CryoLife. "This is a critical product milestone, and more importantly, this decision will allow many more patients to experience the benefits of BioGlue."
According to industry estimates, surgical adhesives represent an annual worldwide market of approximately $2 billion.
Specifically, the new Canadian approval includes BioGlue's use for genitourinary, dural, alimentary tract (which includes esophageal, gastrointestinal, and colorectal tissues) and other abdominal soft tissues, such as pancreatic, splenic, hepatic, and biliary. BioGlue may also be used to attach surgical meshes in hernia repair.