The FDA has given US company AVECOR Cardiovascular 510(k) marketing clearance for its Affinity oxygenator with Trillium bio-passive surface. All blood-contact surfaces of oxygenators are coated with a non-leaching synthetic hydrophilic polymer containing a small amount of heparin. The bio-passive surface minimises activation of blood constituents which would occur as a result of contact with this synthetic coating.
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