Tissue engineered heart valve to enter human trials:
This article was originally published in Clinica
Executive Summary
US company CryoLife plans to begin human trials of a new tissue-engineered heart valve which combines living human cells with a porcine heart valves to mimic more closely a natural human valve. The Atlanta, Georgia-based company plans to submit an investigational device exemption to the US FDA in the fourth quarter of 1999 for its SynerGraft technology. Last month, the company announced that SynerGraft porcine valves implanted in sheep were functional and showed no signs of calcification after 160 days.