Pharmaceutical and device company Angiotech Pharmaceuticals (Vancouver, British Columbia) said it intends to file for FDA clearance of its anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).

A pivotal study of Angiotech’s 5-FU CVC met its primary goal for effectiveness, according to the company. The primary endpoint involved comparing the 5-FU CVC to another anti-infective catheter to evaluate the prevention of bacteria growth.

Angiotech completed enrollment of 960 patients in the clinical trial in July (Medical Device Daily, July 12, 2007). The company plans to present the study results next year at the 37th Critical Care Congress, hosted by the Society of Critical Care Medicine (Des Plaines, Illinois), Feb. 2-6 at the Hawaii Convention Center.

The company expects to submit a 510(k) package to the FDA in 4Q07. Pending regulatory approval, Angiotech says it anticipates launching the 5-FU CVC product line in 2008.

“After reviewing the data from our recently completed clinical trial, we are extremely pleased that the 5-FU CVC pivotal study has hit its primary efficacy endpoint while showing an excellent safety profile. We are looking forward to presenting the full data set in a scientific symposium at the upcoming Critical Care Congress in February,” said William Hunter, MD, president/CEO of Angiotech.

“To me the importance for this for Angiotech is it’s a platform-type technology for the company,” Hunter told Medical Device Daily.

CVCs 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.

While infection is a common complication associated with just about any implantable device, Hunter said CVC was the right product to try 5-FU on first.

“When patients get an infection from a CVC they have a 50% chance of dying ... it’s a terrible price for a patient to pay,” Hunter said.

In looking for a drug that would work as effectively as traditional antiseptics and antibiotics at preventing catheter-related infections, without the risk of creating a “super bug” that could spread throughout a hospital, Hunter said Angiotech found 5-FU, an approved anti-cancer drug. The advantage of using 5-FU, he said, is that it has no clinical application as either a systemic antibiotic or a hospital antiseptic so “you don’t take any additional risk by using it.”

The hope behind using 5-FU on a CVC, according to Angiotech, is that the drug appears to effectively stop bacteria from entering the bloodstream, which can occur with implanted catheters.

In the U.S., the cost per catheter-related infection can range from $3,700 to $29,000. In addition, the Centers for Disease Control and Prevention (CDC; Atlanta) has raised concerns about the overuse of traditional antibiotics, which can contribute to an increase in the antibiotic resistance of bacteria.

“This is an exciting milestone for Angiotech. Our R&D efforts are striving to address two of the most common problems in surgery and medical devices: restenosis following vascular injury and infection related to medical device implantation. We continue to work towards achieving success in one of the most challenging areas of medical device development by deriving new and useful applications for our leading drug platforms, paclitaxel and 5-FU, and taking them from their early stages in the lab to their actual clinical use,” said Jeff Walker, MD, senior VP of R&D for Angiotech.

Angiotech says it expects the 5-FU CVC to be its first product line to be completely researched, developed and commercialized using internal resources, personnel and technologies, many of which were obtained through previous acquisitions the company completed.

Angiotech develops treatments for diseases or complications associated with device implants, surgical interventions and acute injury.