FDA clears Teleflex’s ARROW PICC with Chloragard technology

Teleflex Incorporated (NYSE:TFX) announced today that in addition to broad-spectrum antimicrobial protection, the pressure-injectable ARROW^® PICC with Chloragard^® Technology provides antithrombogenic protection for at least 30 days. It's the world's first central venous catheter to significantly reduce the risk of two common complications associated with peripherally inserted central catheters, compared to traditional uncoated PICCs.    

Chloragard technology uses a proprietary formulation and process providing a controlled release and availability of chlorhexidine on catheter surfaces. The initial FDA cleared claim of 99.99% colonization reduction for at least 30 days against bacterial and fungal pathogens has now been enhanced by the following ground-breaking claims:

• 61% reduction in thrombus accumulation on catheter surfaces after 30 days
• When challenged with infection, 92% reduction in thrombus accumulation on catheter surfaces after 30 days
• Reduced thrombotic intraluminal occlusion
• Reduction in phlebitis and an average of 72% less intimal hyperplasia after 30 days

"Teleflex's proprietary coating that provides this enhanced antithrombogenic protection is the result of years of research and a perfect example of our commitment to develop better clinical outcomes, while reducing health care costs for our customers and their patients," said Benson Smith, Chairman, President and CEO.

Fibrin formation can occur on internal or external catheter surfaces, creating serious clinical concerns for patients with PICCs. Fibrin attachment on internal catheter surfaces can lead to partial or complete catheter occlusion, resulting in delay of patient therapy, increased length of hospital stay, or costly declotting processes. Catheter occlusion is the most common noninfectious complication in the long-term use of central lines.

Fibrin formation on external catheter surfaces can influence complete occlusion of the vessel or catheter tip. Published rates of PICC associated symptomatic upper extremity vessel thrombosis vary from 3.0% - 7.8%, while asymptomatic rates are as high as 38.5%. Thrombosis has also been shown to have a correlation to bloodstream infection.

The health economic impact is also significant, with average cost of care for upper extremity vessel thrombosis exceeding $11,000 per incident and cost of care for CLABSI exceeding $29,000 per incident.

"The ARROW PICC with Chloragard technology has demonstrated the ability to protect against infection and now thrombosis for at least 30 days; it's a world first and not available from any other company," said Paul Molloy, President of Teleflex Vascular Division. "Together with our market-leading ARROW^® VPS^® catheter tip location technology, we offer a clinical utility and health economic benefits array unmatched by any other company. Our vision is to make zero complications in vascular care a reality and to lead the world in pioneering advanced medical technology."

In accordance with national recommended guidelines, the ARROW^® PICC with Chloragard^® technology is currently available in an ergonomically designed, sharps safety, maximal barrier kit that reduces the risk of infection and accidental needle sticks at insertion. Kit configurations for insertion in the Interventional Radiology setting are also available.