As observed in the testing, the Vantex CVC with Oligon material provides a biocompatible central venous catheter with less potential risk for allergic response than a chlorhexidine/ silver sulfadiazine (antiseptic) coated CVC. The potential for improved device compatibility plus the potential to reduce bacterial growth demonstrates that the Vantex CVC with Oligon material is an excellent alternative over an antiseptic-coated CVC.
Torricelli R, Wuthrich B. Life-threatening anaphylactic shock due to skin application of chlorhexidine. Clin Exp Allergy. 1996;26:112 Gabler WL, Roberts D, Harold W. The effect of chlorhexidine on blood cells. J Periodontal Res. 1987;22:150-155. Butler WH, Iswarah TJ. Chlorhexidine: Safety Evaluation. Royal Society of Medicine, International Congress and Symposium. Series Number 23. Center for Devices and Radiological Health. FDA Public Health Notice, Potential Hypersensitivity Reactions to Chlorhexidine-Impregnated Medical Devices. March 1998.
Antimicrobial activity on the Oligon surface and inner lumens of the catheter during handling and placement has been demonstrated through in vitro testing against organisms commonly associated with nosocomial infections. The activity of the antimicrobial agents is localized at the catheter surfaces and is not intended for treatment of systemic infections.
In vitro testing demonstrated that the Oligon material provided broad spectrum effectiveness (≥ 3 log reduction from initial concentration within 48 hours) against the organisms tested: Staphylococcus aureus, Staphylococcus epidermidis, Klebsiella pneumoniae, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae, Enterobacter aerogenes, GMRSa and Pseudomanas aeruginosa. The impact of Oligon material on infection rates has not been demonstrated.
*Contact inhibition of microbial growth on surface of catheters. Effective against organisms commonly associated with nosocomial infection, e.g., S. epidermidis.
Antimicrobial activity associated with AMC THROMBOSHIELD (an Antimicrobial Heparin Coating) has been demonstrated using in vitro agar diffusion assays against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens and Acinetobacter calcoaceticus.
Data on file.
Edwards Lifesciences, Edwards, the stylized E logo and AMC THROMBOSHIELD are trademarks of Edwards Lifesciences Corporation. Vantex is a trademark of Edwards Lifesciences Corporation and registered in the U.S. Patent and Trademark Office. Oligon is a trademark of Implemed, Inc.
See instructions for use for full prescribing information.
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