This article was originally published in The Gray Sheet
Minneapolis firm begins marketing its Affinity non-occlusive, pressure-regulated blood pump with Trillium bio-passive surface coating following 510(k) clearance, the company says. The coating, which contains a non-leaching synthetic hydrophilic polymer with a small amount of heparin, is designed to "minimize activation of blood constituents which otherwise occurs as a result of contact with conventional synthetic surfaces." The company launched the Affinity system in the U.S. in August ("The Gray Sheet" Aug. 18, 1997, In Brief)...
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