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Angiotech announces intent to file 510(k) for its innovative 5-FU Central Venous Catheter (CVC) based on positive results from pivotal trial
Date:10/9/2007

Angiotech's first product line to be completely researched, developed and commercialized using internal resources, personnel and technologies, many of which were obtained through previous acquisitions completed by Angiotech.

In July 2007, Angiotech completed enrolment of 960 patients in the clinical trial of its 5-FU CVC, which was one of the largest CVC studies ever conducted. Designed as a randomized, single-blind, active-controlled, two-arm, multi-center clinical study, the primary objective is to compare the Angiotech 5-FU CVC to a leading anti-infective catheter with regards to preventing bacterial colonization.

Angiotech plans to present the 5-FU CVC pivotal study results at the "37th Critical Care Congress" hosted by the Society of Critical Care Medicine, which will be held on February 2-6, 2008 at the Hawaii Convention Center.

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)

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.

About Catheter-Related Infections

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 coating to prevent catheter-related i
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SOURCE Angiotech Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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