FDA approves Affinity Pixie Oxygenation System (Medtronic Inc) for use in Heart Surgery on children - 28-Oct-2012
The FDA have given 510(k) clearance for the Affinity Pixie Oxygenation System, from Medtronic Inc, for use 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. It gained the CE mark in the EU in May 2010 and is now currently available for use in more than 50 countries worldwide.
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