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The European Union has granted CE mark approval to the Medtronic-developed oxygenator, which is designed to oxygenate and remove carbon dioxide from blood during open-heart surgical procedures.

The Affinity Fusion oxygenation system, which the company claims serves as a patient’s temporary lungs, uses a proprietary fibre winding process with an interlaced pattern to filter the blood and remove particles and air bubbles.

Smooth tubular pathways and a curved venous inlet tube are incorporated into the system to reduce blood turbulence.

The system also features an oxygenator system holder, which is designed to improve flexibility and ease of use during surgeries in operating rooms with limited space.

St George’s Hospital chief clinical perfusionist Simon Phillips said the equipment should be designed to maximise patient safety while performing cardiopulmonary bypass.

“Being part of the collaboration process during the Affinity Fusion oxygenation system development, I am confident that this new technology will benefit patients who undergo these lifesaving procedures and the surgical teams that use it,” Phillips said.

Medtronic structural heart division senior vice president, president and cardiac surgeon Dr John Liddicoat said; “With so many patients who undergo cardiac surgery each year, Affinity Fusion provides patients with a reliable oxygenation system they can count on.”

Although the device is not currently available in the US, the company intends apply for clearance from the Food and Drug Administration.

Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha’Eri.