Teleflex PICC receives FDA 510(k) clearance for central venous pressure monitoring

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, today announced its ArrowADVANTAGE⁵ pressure-injectable peripherally inserted central catheter (PICC) has received FDA 510(k) clearance for central venous pressure (CVP) monitoring indication. CVP measurement in patients is one of the most important assessments in determining cardiovascular function. The change in CVP, correlated with the patient's clinical status, is a useful indication of adequacy of venous blood volume and alterations in cardiovascular function. CVP also reflects the pumping ability of the right atrium and ventricle.

“Venous Thrombosis Related to Peripherally Inserted Central Catheters.”

"With the ArrowADVANTAGE⁵, we offer the next generation of non-coated pressure-injectable PICCs," commented Paul Molloy, president, Vascular Division of Teleflex. "Beyond the unique advantages of our PICC, we are pleased to add the CVP monitoring indication. Additionally, the distal lumen is compatible with the ARROW^® VPS^® System, enabling clinicians to combine the advantages of our PICC with state-of-the-art tip location technology."

The ArrowADVANTAGE⁵ catheter provides features clinicians have come to expect in a PICC, plus five unique advantages. The design was developed for clinician ease-of-use, smooth insertion and patient comfort.

Product Design Features for Ease-of-Use, Patient Safety and Comfort

ArrowADVANTAGE⁵ PICCs have increased radiopacity for visualization under fluoroscopy and x-ray, 5 ml/sec pressure injection indication in the distal lumen, CVP monitoring capability and compatibility with the ARROW^® VPS^® stylet. Additional features unique to the ArrowADVANTAGE⁵ PICC include:

• Arrow Blue FlexTip^®, designed to minimize vessel trauma
• Staggered exit ports, to reduce the risk of incompatible medications mixing and forming precipitate
• GlideThru™ peel-able sheath over dilator, to reduce the need for a skin nick
• SecondSite™ adjustable hub, to fasten the catheter at an insertion site anywhere along the catheter body
• TaperFree™ catheter design, to minimize risk of catheter-related thrombosis.

Catheter-related thrombosis is an important clinical matter to consider. A study in the Journal of Vascular and Interventional Radiology reported that the risk of thrombosis increases as French size increases. In this study, thrombosis rates increased more than nine fold when comparing 4Fr to 6Fr sized catheter thrombosis outcomes. Tapered catheter bodies can have considerable difference in French size between the tip and proximal end, putting the widest portion of the catheter into the narrowest portion of the vein.

Maximal Barrier Precautions Tray Supports Adherence to Guidelines

The ArrowADVANTAGE⁵ PICC is packaged with the Arrow^® ErgoPack^™ System, which provides Maximal Barrier Precautions and equips caregivers with 30 systematically organized essential tools to follow guidelines recommended by leading organizations. These include the Centers for Disease Control and Prevention (CDC), Society for Healthcare Epidemiology of America (SHEA) and the Institute for Healthcare Improvement (IHI).