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EU grants CE mark to Medtronic’s new oxygenation system

Medtronic has received CE mark from the European Union (EU) for the development of a new oxygenator, designed to oxygenate and remove carbon dioxide from blood, while performing various open-heart surgical procedures.

Serving as patient’s temporary lungs, the Affinity Fusion oxygenation system utilizes a proprietary fiber winding process with an interlaced pattern to filter the blood and remove particles and air bubbles that enter the blood.

The system includes smooth tubular pathways and curved venous inlet tube which are designed to reduce blood turbulence that occur during the surgical procedure.

The Affinity system also features a new oxygenator system holder which enables perfusionists to improve flexibility and ease of use during performing surgeries in operating rooms with limited space.

St George’s Hospital chief clinical perfusionist Simon Phillips said, "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."

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."

The company is planning to submit an application to the US Food and Drug Administration for clearance of its new oxygenator.