Teleflex Inc. (TFX) said that it receives FDA 510(k) clearance for Antithrombogenic claims on its ARROW peripherally inserted central catheter or PICC with Chlorag+ard Technology.
Teleflex said that in addition to broad-spectrum antimicrobial protection, the pressure-injectable ARROW PICC with Chlorag+ard Technology provides antithrombogenic protection for at least 30 days.
The company said that Chlorag+ard technology uses a proprietary formulation and process providing a controlled release and availability of chlorhexidine on catheter surfaces. The initial FDA cleared claim of 99.99% colonization reduction for at least 30 days against bacterial and fungal pathogens has now been enhanced by the certain ground-breaking claims.
The claims are 61% reduction in thrombus accumulation on catheter surfaces after 30 days; When challenged with infection, 92% reduction in thrombus accumulation on catheter surfaces after 30 days; Reduced thrombotic intraluminal occlusion; Reduction in phlebitis and an average of 72% less intimal hyperplasia after 30 days.
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