Angiotech Pharmaceuticals has received 510(k) clearance from the FDA to market its innovative 5-Fluorouracilcoated Central Venous Catheter in the US.
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Angiotech has demonstrated the ability of 5-Fluorouracilcoated (FU), a well-known and FDA approved drug, to prevent catheter-related infections as compared with CH-SS coated catheters.
The principle behind using 5-FU on a Central Venous Catheter (CVC) is that the drug acts through multiple pathways to inhibit bacterial growth and metabolic functions of most microorganisms. Adding a very minute amount of 5-FU to the surface of a device makes that surface a hostile environment for a microorganism, with unchanged tolerability for the patient. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted devices, making them less likely to serve as reservoirs for additional infection.
William Hunter, president and CEO of Angiotech, said: “The 5-FU CVC represents our first drug-eluting medical device product to be researched and developed completely in-house by Angiotech’s R&D and clinical teams, without the aid of a corporate partner.”
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