FDA Clears Medtronic’s Affinity Pixie® Pediatric Oxygenation System

In short

Medtronic, Inc. has gained U.S. FDA 510(k) clearance and the first U.S. clinical use of its new Affinity Pixie® Oxygenation System. The company says the system allows for broad use in children of various sizes and easy set-up and use by perfusionists during lifesaving cardiopulmonary bypass surgeries in neonates, infants and small children, including those with congenital heart defects.


Approximately 25 percent of the 32,000 infants born each year in the United States with congenital heart defects require invasive treatment within the first year of life¹, 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 defect².

All of this sets the scene for Medtronic’s Affinity Pixie Oxygenation System, which 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.

Company comments

“Medtronic is committed to investing its resources to provide successful therapies to underserved populations, including pediatric patients,” said John Liddicoat, M.D., senior vice president, Medtronic and president of the Structural Heart business“The Affinity Pixie Oxygenation System is the latest innovation in Medtronic’s expanding portfolio of products for pediatric cardiac patients, which includes transcatheter pulmonic valves, cannula products, arterial filters and temporary pacing leads

Regulatory status

The Affinity Pixie Oxygenation System with Balance® Biosurface gained CE Mark in May 2010, and is currently available for use in more than 50 countries worldwide.


¹ American Heart Association – 2012 Congenital Cardiovascular Defects Fact Sheet

² http://www.cdc.gov/ncbddd/heartdefects/facts.html

Source: Medtronic, Inc.