The FDA has granted Medtronic 510(k) clearance for its Affinity Pixie oxygenation system.
Affinity Pixie allows for broader use in children of various sizes and set-up and use by perfusionists during cardiopulmonary bypass surgeries in neonates, infants and small children, including those with congenital heart defects, according to the Minneapolis-based Medtronic.
The system serves as a child’s lungs during cardiopulmonary bypass surgery by removing carbon dioxide and adding oxygen to the child’s blood before returning it to the body. It also cools or warms the blood to attain the desired body temperature. During open-heart surgery, blood is routed away from the child’s heart and lungs through the cardiopulmonary bypass circuit that includes the oxygenation system, creating a bloodless, motionless field, the company said.
Affinity Pixie with Balance Biosurface gained CE Mark in May 2010.