Medtronic Gains FDA Clearance for New Pediatric Oxygenation System for Neonate

Medtronic, Inc. MDT today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the first U.S. clinical use of its new Affinity Pixie^® Oxygenation System. The system allows for broader use in children of various sizes and easy set-up and use by perfusionists during lifesaving open-heart (cardiopulmonary bypass) surgeries in neonates, infants and small children, including those with congenital heart defects.  The Affinity Pixie Oxygenation System serves as a child's lungs during open-heart 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, thereby creating a bloodless, motionless field, which is what allows surgeons to perform complex procedures on the heart intended to correct the defect or improve heart function.