CryoLife's cardiac patch approved in US
This article was originally published in Clinica
The CryoPatch SG pulmonary human cardiac patch developed by CryoLife has received 510(k) clearance from the US FDA for the repair of the right ventricular outflow tract. This surgery is commonly performed in children with congenital heart defects – a market worth $15m in the US. Launch is set for the third quarter of 2009. The patch is produced using the Kennesaw, Georgia company's SynerGraft technology, which removes allogeneic donor cells and cellular remnants from donated tissue, avoiding immunological rejection.