VANCOUVER, Dec. 17 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its innovative, anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).
"We are pleased to complete the submission of a 510(k) application to the FDA for our 5-FU CVC, as we believe this represents another important step towards commercializing this product line and developing our 5-FU anti-infective platform," said Dr. William Hunter, President and CEO of Angiotech.
Pending the receipt of all necessary regulatory approvals, Angiotech anticipates launching the commercial 5-FU CVC product line in 2008.
About Central Venous Catheters (CVC) and Catheter-Related Infections
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. In the U.S., the cost per catheter-related infection can range from $3,700 to $29,000(1). In addition, the Centers for Disease Control and Prevention (CDC) has raised concerns about the overuse of traditional antibiotics, which can contribute to an increase in the antibiotic resistance of bacteria.
About Angiotech's 5-FU CVC
Angiotech believes that 5-FU, a well-known and approved compound, has
the potential to be used as a coat
|SOURCE Angiotech Pharmaceuticals, Inc.|
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