FDA Clears “Lungs” for Children’s Open-Heart Surgery

Officials at Medtronic Inc. announce 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.

The Affinity Pixie Oxygenation System was first used in the United States last week at Advocate Christ Medical Center in Oak Lawn, IL. The Affinity Pixie Oxygenation System with Balance Biosurface gained CE (Conformité Européenne) Mark in May 2010, and is currently available for use in more than 50 countries worldwide.

A congenital heart defect is a condition, present at birth, in one or more structures of the heart or blood vessels. Approximately 25% of the 32,000 infants born each year in the United States with congenital heart defects require invasive treatment within the first year of life, and some children require additional procedures as they grow older. Due to advances in medical care, infants born with congenital heart defects are living longer and healthier lives. Today an estimated one million adults in the United States are living with a congenital heart defect.

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