Cryolife's BioGlue
This article was originally published in The Gray Sheet
Executive Summary
Atlanta-based firm says it will commence studies in late June to evaluate the surgical adhesive for aortic dissections under an approved conditional investigational device exemption. The final protocol, including the number of patients and centers to be enrolled and the clinical endpoints, still must be hashed out between Cryolife and agency officials. The product gained a CE mark Jan. 6 and began shipping in Europe in mid April