In addition to meeting the non-inferiority endpoint, these data show a trend toward superiority for the 5-FU coated catheter over the market leading device, both in frequency and nature of colonizations and infections. This efficacy comes without the public health risk that accompanies the long-term, low level exposure to important anti-microbials such as chlorhexidine and silver sulfadiazine or antibiotics like rifampin. Angiotech's ground breaking 5-FU technology achieves improved anti-infective performance without the risk of clinically meaningful bacterial or fungal resistance, a unique property among anti-infective coatings.
"We are extremely pleased with the clinical results of the 5-FU CVC trial. Achieving zero percent blood stream infection bodes well for a most vulnerable patient population and has very positive implications for the expansion of our 5-FU anti-infective platform. To observe substantial anti-infective performance without exposure to antiseptics or antibiotics is very important to all clinicians, especially infectious disease and infection control experts," said Dr. William Hunter, President and CEO of Angiotech.
Angiotech submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its 5-FU CVC in December 2007 and is finalising commercialization plans for the product.
About the Study
This study was a multi-center (25 U.S. sites), randomized clinical trial conducted to compare the efficacy of our novel 5-FU-eluting CVC to a CH-SS coated CVC in preventing catheter colonization, local site infection and CRBSI.
About CVC and Catheter-Related Infections
Central venous catheters are usually inserted into critically ill
patients for extended periods of time to administer fluids, drugs, and
nutrition, as well as facilitate frequent blood draws. One of the
complications associated with CVC implantation is infection, which can
|SOURCE Angiotech Pharmaceuticals, Inc.|
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