Angiotech receives FDA clearance to market 5-Fluorouracil-coated central venous catheter

Apr 17 2008

Angiotech Pharmaceuticals, Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its innovative 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC) in the United States.

"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," said Dr. William Hunter, President and CEO of Angiotech. "This is an important milestone in our Company's history, and we look forward to moving into the commercial phase of our 5-FU CVC product, as well as developing other implantable devices that utilize this novel and proprietary anti-infective technology platform."

The clinical data from Angiotech's 960 patient clinical trial comparing its 5-FU CVC with a chlorhexidine/silver sulfadiazine (CH-SS) coated CVC was recently presented by clinical investigators at the 28th International Symposium on Intensive Care and Emergency Medicine in Brussels. The study met its primary non-inferiority endpoint and there were no occurrences of clinically evident blood stream infection in patients treated with Angiotech's 5-FU CVC.

Angiotech has demonstrated that 5-FU, a well-known and FDA approved drug, has effectively demonstrated its ability to prevent catheter-related infections as compared with CH-SS coated catheters. In addition, since 5-FU is not routinely used as either a systemic antibiotic or a hospital antiseptic, there may be a reduced risk to the hospital or the community at-large of creating a "super-bug" that is resistant to useful classes of antibiotics and antiseptics and may make infection control more complex. The alarming increase in microbial resistance is one of the Centers for Disease Control and Prevention's top concerns, and the 5-FU CVC represents an effective and important step towards preserving valuable antibiotic and antiseptic agents which currently have widespread use in the hospital and community settings.

The principle behind using 5-FU on a 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.