CryoLife
This article was originally published in The Gray Sheet
Executive Summary
Gains investigational device exemption for animal protein-based surgical adhesive BioGlue. The study, which is scheduled to begin as early as July, will include about 300 patients at 20 sites in the U.S. CryoLife expects the trials to be completed in 18-24 months, at which time the firm will submit a premarket approval application to FDA. In January, BioGlue gained a CE mark for vascular sealing and reconstruction surgeries