A proprietary—CryoLife—adhesive used to repair aortic dissections, seal vessels, and reconstruct and reinforce peribronchial soft tissue to decrease air leaks
Composition Bovine serum albumin and glutaraldehydeare dispensed via a double-chambered syringe. Once dispensed, the adhesive components mix within the applicator tip where the cross-linking begins (within 20 to 30 seconds; it reaches bond strength within 2 minutes). The glutaraldehyde molecules bond with the BSA molecules creating a flexible mechanical seal independent of the body's clotting mechanism.
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Earlier this month, we received an expanded indication for BioGlue in Japan, which doubled our market opportunity and is consistent with our strategy to gain new indications for our product portfolio.
CryoLife, Inc, Atlanta, GA, announced that its BioGlue Surgical Adhesive has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in the repair of aortic dissections.
With the help of micro-manipulation technique, the researchers measured the force needed to overcome the bioglue adhesion, and showed that dried biofilm stuck 20-times more tightly than fresh biofilm.
BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.
BioGlue is also CE marked in the European Community and approved in Canada for use in soft tissue repair and in Australia for use in vascular and pulmonary sealing and repair.
In addition, on April 21st, the company's BioGlue surgical adhesive was the subject of a paper presented by Dr.
BioGlue is now indicated for adhesion and support of hemostasis for aortotomy closure sites, suture/anastomosis sites (including aortic dissection and anastomosis sites with a use of a prosthetic graft), and suture sites on the heart.
BioGlue is CE marked in the European Community and approved in Canada for use in soft tissue repair.
we remain on track with our regulatory efforts to expand the indication for BioGlue in Japan later in 2015.
Atlanta, GA, announced it has received FDA approval of a new disposable delivery system for BioGlue Surgical Adhesive.
NYSE:CRY), the leader in the development and commercialization of living human tissue implantable devices and a manufacturer and distributor of stentless heart valves and surgical adhesives, today announced that it has received approval from the Institutional Review Boards (IRB) at 83 hospitals in the United States for the use of BioGlue surgical adhesive in acute thoracic aortic dissections.
Our third quarter results reflect good growth in our higher margin product categories, including BioGlue, HeRO Graft, and PerClot.