IDE requested for "self-growing" heart valve:
This article was originally published in Clinica
Executive Summary
CryoLife has submitted an investigational device exemption (IDE) application to the FDA to begin US trials of its SynerGraft tissue-engineered pulmonary heart valve, intended for children. The product is a collagen frame based on a porcine valve from which the cells have been removed. Animal studies show that the frame is re-populated by the recipient's own cells and grows as the recipient grows. Six Australian adults already have SynerGraft implants and all are "doing well", says the Atlanta, Georgia-based company. It hopes the US trials will recruit up to 150 pediatric patients. Meanwhile European regulators are considering the product for CE-marking, the company claims.