Angiotech 5-FU Catheter to Reduce Infections Approved
The new 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC), manufactured by Angiotech Pharmaceuticals, received marketing approval (pdf) by the Food and Drug Administration. The device is intended to reduce the likelihood of infections. News of the marketing approval was described in a press release issued by Angiotech.
5-FU, a drug which already has FDA approval, is commonly used in chemotherapy regimens. In addition, studies indicate that this product is associated with a decreased rate of catheter-related infections compared to chlorhexidine/silver sulfadiazine (CH-SS) coated CVCs.
5-FU works through multiple pathways to prevent the metabolic functions of many microorganisms, as well as inhibiting the growth of bacteria. A minuscule amount of 5-FU is added to the catheter surface, creating a hostile environment for bugs without limitations with respect to patient use.
One potential benefit of this approach is the ability to prevent the development of biofilms on implanted device impregnated with 5-FU. This makes the 5-FU CVCs less likely to become reservoirs for infection.
One benefit of using 5-FU for this indication is that this drug is not often utilized as either a hospital antiseptic or systemic antibiotic. It is speculated that use of this drug in this manner may reduce the likelihood that another “super-bug” (such as MRSA) will develop. Additionally, availability of this device preserves existing antiseptic and antibiotic agents that are currently used across varied healthcare settings and, particularly, to treat superbugs.
Study findings presented at the International Symoposium on Intensive Care and Emergency Medicine indicated that none of the patients treated with the 5-FU CVC developed a clinically evident blood stream infection. That trial recruited over 950 patients, comparing the Angiotech device to CH-SS CVCs.
The 5-FU CVC is the first drug-eluting device developed and manufactured by Angiotech. The company plans to develop additional devices using this approach to reduce infection rates.
April 21, 2008 Related topics: Product Approval & Certification, Hygiene & Cleanliness