Affinity Fusion oxygenation system for adult cardiac surgery gets the CE mark


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

The Affinity Fusion oxygenation system’s new design enhancements include:

  • A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood, which may reduce the risk of stroke;
  • Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure;
  • Enhanced setup and customisation capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space. 


“The new Affinity Fusion oxygenator is designed to provide perfusionists with the most innovative and enhanced product of its kind,” said John Liddicoat, senior vice president and president of Medtronic’s Structural Heart division. “With so many patients who undergo cardiac surgery each year, Affinity Fusion provides patients with a reliable oxygenation system they can count on.”

“During cardiopulmonary bypass, it is imperative that the equipment is designed to maximise patient safety, yet is also sophisticated, versatile and simple to use,” said Simon Phillips, chief clinical perfusionist at St George’s Hospital in London, UK. “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.”

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