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.