U.S. regulators have cleared a surgical system made by Medtronic Inc. that is used during open-heart surgery on children.
The Fridley-based medical technology giant said the Affinity Pixie Oxygenation System allows for broader use in children of various sizes during cardiopulmonary bypass surgery in newborns, infants and small children, including those with congenital heart defects.
The system serves as the 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, Medtronic said. It also cools or warms the blood to 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 and motionless area that allows surgeons to perform complex procedures on the heart to correct defects.
About 25 percent of the 32,000 infants born in the United States each year with congenital heart defects require invasive treatment to correct the problem.
The Affinity system first was used in the United States last week at Advocate Christ Medical Center in Oak Lawn, Ill. The system was approved in Europe in May 2010 and is currently available in more than 50 countries. Clearance in the United States was granted recently by the Food and Drug Administration.
"Medtronic is committed to investing its resources to provide successful therapies to underserved populations, including pediatric patients," said Dr. John Liddicoat, a senior vice president and president of the Structural Heart business at Medtronic.
JANET MOORE
