FDA clears Medtronic's Affinity Fusion blood oxygenation system

April 2, 2013 by Brad Perriello

The FDA grants 510(k) clearance to Medtronic's Affinity Fusion blood oxygenation systems, designed to replicate the lungs' function during open heart surgeries.


Medtronic (NYSE:MDT) said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs.

The Minneapolis-area medical device company, which is the world's largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient's blood to remove particles and air during oxygenation.

The device also includes what Medtronic claims is "a first-of-its-kind curved venous inlet tube" designed to reduce blood flow turbulence, according to a press release.

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The Affinity Fusion oxygenator won CE Mark approval in the European Union in September 2012.