The device routes blood away from the child’s heart and through a bypass circuit that removes carbon dioxide, adds oxygen and warms or cools the blood to match a desired body temperature before returning it to the body, according to a press release.
"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," Medtronic senior vice president and structural heart business president Dr. John Liddicoat said in prepared remarks.
Medtronic also noted 1st U.S. use of the device, which took place last week at Advocate Christ Medical Center in Oak Lawn, Ill.
The device since May 2010 has had CE Mark approval for use in the European Union, and is currently on the market in more than 50 countries.
The win is good news for the medtech giant, which is under pressure from U.S. regulators over its handling of a controversial bone morphogenetic protein sold under the company’s Infuse label.
A U.S. Senate report released this week said the company deliberately obscured evidence of adverse events and promoted off-label use of the product and paid out millions to the doctors who co-wrote positive studies.