Medtronic nets CE Mark for oxygenation system for open heart surgeries

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Medtronic has received CE Mark for its new Affinity Fusion oxygenation system in Europe, which is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open heart surgical procedures.

The system's updates are designed to prevent and remove air bubbles that can enter the blood during the procedure. The other updates include: ·        

  • A fiber winding process with an interlaced pattern that filters the blood and removes particles and air while oxygenating the blood;
  • Tubular pathways for blood to pass through and a curved venous inlet tube; and
  • Enhanced setup and customization capabilities, including a new oxygenator system holder. 

The Fusion oxygenation system is used by perfusionists during open heart surgical procedures that require a bloodless, motionless surgical field, such as lifesaving cardiopulmonary bypass surgery. 

The Affinity Fusion oxygenator is not available in the U.S., but Medtronic plans to submit an application for U.S. clearance.