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May 28, 2012
FDA Clears Antithrombogenic Claims for Teleflex's Arrow PICC With Chloragard Technology
May 21, 2012—Teleflex Inc. (Limerick, PA) announced the US Food and Drug Administration 510(k) clearance for antithrombogenic claims on its Arrow peripherally inserted central catheter (PICC) with Chloragard technology. Chloragard is designed to reduce colonization of pathogens responsible for causing central line–associated bloodstream infections using a formulation and process that provides a controlled release and availability of chlorhexidine on catheter surfaces.
The pressure-injectable Arrow PICC with Chloragard technology is now cleared to claim that it provides antithrombogenic protection for at least 30 days and significantly reduces the risk of two common complications associated with PICCs, compared to uncoated devices.
The initial FDA-cleared claim was a 99.99% colonization reduction for at least 30 days against bacterial and fungal pathogens. According to the company, the newly revised claims include a 61% reduction in thrombus accumulation on catheter surfaces after 30 days; a 92% reduction in thrombus accumulation on catheter surfaces after 30 days when challenged with infection; reduced thrombotic intraluminal occlusion; reduction in phlebitis and an average of 72% less intimal hyperplasia after 30 days.
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