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FDA approves Teleflex non-coated peripherally inserted central catheter

The US Food and Drug Administration (FDA) has granted 510(k) approval to Teleflex Incorporated's ArrowADVANTAGE5 non-coated pressure-injectable peripherally inserted central catheter (PICC) for central venous pressure (CVP) monitoring indication.

Teleflex said CVP reflects the pumping ability of the right atrium and ventricle, and the changes in CVP measurement indicates adequacy of venous blood volume and alterations in cardiovascular function.

In addition to CVP monitoring capability, ArrowADVANTAGE5 PICCs have increased radiopacity for visualization under fluoroscopy and x-ray, 5 ml/sec pressure injection indication in the distal lumen, and compatibility with the ARROW VPS stylet.

Teleflex vascular division president Paul Molloy said, "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."

Additional features of 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.

The solution also features 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 as well as TaperFree catheter design to minimize risk of catheter-related thrombosis.