Medical devices and tissue processing company CryoLife Inc. (CRY) has reportedly received the Japanese “Shonin” clearance (pre-market approval) to market its BioGlue surgical adhesive. The product will be distributed in Japan by the company’s partner Century Medical in first half of 2011 for use in the repair of aortic dissections, a subset of cardiac surgery.
BioGlue is a leading surgical adhesive used in cardiovascular surgery globally. Since its launch in 1998, the product has been used in more than 600,000 procedures. BioGlue is currently approved in the U.S. for use in open surgical repair of large vessels in adult patients. The product is cleared for marketing in Europe for use in cardiac/vascular, pulmonary and soft tissue repairs. It is also approved in Canada and Australia .
BioGlue has two adhesive components that are dispensed by a controlled delivery system. Following its application to the tissue proteins at the repair site, BioGlue creates a flexible mechanical seal (within 20 to 30 seconds) independent of the body’s clotting mechanism. It reaches maximum bonding strength within two minutes.
The Shonin approval of BioGlue has broadened the application and adoption of this novel product. Japan represents the second largest market (after the U.S. ) for surgical hemostats and sealants. The Japanese market for adhesive and sealants is estimated at around $150 million annually while the market for surgical adhesives for the repair of aortic dissection is pegged at roughly $10 million.
CryoLife is a leader in the processing and distribution of implantable human tissues for use in cardiac and vascular surgeries across the U.S. and Canada. Increased shipment of its heart valve products and cardiac patches contributed to a mid single-digit growth in cardiac revenues for first-half fiscal 2010.
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