FDA Clears Angiotech's 5-FU Central Venous Catheter
April 21, 2008 - Angiotech Pharmaceuticals Inc. said last week it received 510(k) clearance from the FDA to market its 5-Fluorouracil (5-FU) coated central venous catheter (CVC).
The 5-FU CVC is the first drug-eluting medical device to be researched and developed completely in-house by Angiotech's research and development department. The company said it will be stepping stone for development of other implantable devices that utilize the same proprietary anti-infective technology.
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. There were no occurrences of clinically evident blood stream infection in patients treated with Angiotech's 5-FU CVC, the company said.
The study showed 5-FU, an FDA approved drug, has the 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, the company said.
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, the company said. 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.
For more information: www.angiotech.com