CryoLife heart valve
This article was originally published in The Gray Sheet
Executive Summary
Atlanta biomaterials, medical device and tissue processing firm receives 510(k) clearance Feb. 7 for its CryoValve SG pulmonary human heart valve. The valve is manufactured from donated human tissue using the firm's proprietary SynerGraft technology, which removes the tissue cells to leave only a collagen scaffold, and could lower the risk of immune response and subsequent tissue rejection, according to FDA. The product shows particular promise for children with congenital heart defects, the company says. CryoLife is planning a post-clearance study to demonstrate the SynerGraft process' potential and long-term benefits and will begin shipping the valve by April