Angiotech Submits 510(k) to FDA for Anti-infective 5-FU Central Venous Catheter
December 21, 2007 - Angiotech Pharmaceuticals Inc. this week submitted a 510(k) application to the FDA for its new anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).
Pending the receipt of all necessary regulatory approvals, Angiotech anticipates launching the commercial 5-FU CVC product line in 2008.
Central venous catheters (CVC) 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 occur when bacteria contaminate the catheter. CVC infections that progress to bloodstream infections, or septicemia, can become life threatening. The company says in the U.S., the cost per catheter-related infection can range from $3,700 to $29,000. In addition, the Centers for Disease Control and Prevention has raised concerns about the overuse of traditional antibiotics, which can contribute to an increase in the antibiotic resistance of bacteria.
Angiotech believes 5-FU can be used as a coating to prevent catheter-related infections as effectively as traditional antiseptics and antibiotics. In addition, since 5-FU has no clinical application as either a systemic antibiotic or a hospital antiseptic, there is a reduced risk to the hospital or the community at-large of creating a “super-bug” that is resistant to a useful class of antibiotic and can make infection control more complex.
The principle behind using 5-FU on a CVC is that the drug appears to effectively interrupt the colonization of an implanted medical device by those micro-organisms that typically gain entrance to the bloodstream via the local skin penetration of implanted catheters. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted catheters, making them less likely to serve as reservoirs for additional infection.
For more information: www.angiotech.com