Angiotech Pharmaceuticals Inc. 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 a 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 bloodstream infection in patients treated with Angiotech's 5-FU CVC, the company said.