FDA 510(k) Clearance For Teleflex’s ArrowADVANTAGE5 PICC

In short

Teleflex Incorporated has announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter (PICC) has received FDA 510(k) clearance for central venous pressure (CVP) monitoring indication. The announcement comes in a press release issued through Business Wire.


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.

Teleflex says its new catheter was developed for clinician ease-of-use, smooth insertion and patient comfort.

ArrowADVANTAGE5 PICCs have increased radiopacity2 for visualisation 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 precipitate3

• GlideThru™ peelable 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 thrombosis4,5.

User orientation

The ArrowADVANTAGE5 PICC is packaged with the Arrow®ErgoPack™ System, which provides Maximal Barrier Precautions and equips caregivers with 30 systematically organised 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).

Company comments

“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®System1, enabling clinicians to combine the advantages of our PICC with state-of-the-art tip location technology.”


1 Meets VasoNova VPS Stylet requirements for use.

2 Increased radiopacity over currently marketed 4 French and 5 French Arrow Pressure-Injectable PICCs. Data on file. Teleflex Incorporated.

3 Collins JL, Lutz RJ. In Vitro Study of Simultaneous Infusion of Incompatible Drugs in Multilumen Catheters. Heart & Lung. 1991; 20(3):271-7.

4 Grove JR, Pevec WC. “Venous Thrombosis Related to Peripherally Inserted Central Catheters.” Journal of Vascular and Interventional Radiology. 2000; 11: 837-840.

5 Trerotola, S., Stravropoulos, S., Mondeschein, J., Patel, A., Fishman, N., Fuchs, B., Kolansky, D., Kasner, S., Pryor, J., Chittams, J. Triple-Lumen Peripherally Inserted Central Catheter in Patients in the Critical Care Unit: Prospective Evaluation. Radiology. 2010; 256 (1.2).)

Source: Teleflex medical Inc., Business Wire