CryoLife's CryoValve SG
This article was originally published in The Gray Sheet
Executive Summary
Processed human aortic heart valve gains FDA humanitarian use device designation - the first step towards a humanitarian device exemption for replacing diseased, damaged, malformed or malfunctioning native or prosthetic aortic valves in children up to age 21. The firm's SynerGraft technology is used to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix, CryoLife says