Teleflex Receives FDA 510(k) Clearance for CVP Monitoring Indication on the ArrowADVANTAGE5T Pressure-Injectable PICC
LIMERICK, Pa.--(BUSINESS WIRE)--Jul 2, 2012-- 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.
"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(R) VPS(R) System1, 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 radiopacity2 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(R) VPS(R) stylet. Additional features unique to the ArrowADVANTAGE5 PICC include: -- Arrow Blue FlexTip(R), designed to minimize vessel trauma -- Staggered exit ports, to reduce the risk of incompatible medications mixing and forming precipitate3 -- GlideThru(TM) peel-able sheath over dilator, to reduce the need for a skin nick -- SecondSite(TM) adjustable hub, to fasten the catheter at an insertion site anywhere along the catheter body -- TaperFree(TM) catheter design, to minimize risk of catheter-related thrombosis4,5.
Catheter-related thrombosis is an important clinical matter to consider. A study in the Journal of Vascular and Interventional Radiology4 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(R) ErgoPack(TM) 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).
About Teleflex Incorporated Teleflex is a leading global provider of specialty medical devices for a range of procedures in critical care and surgery. Our mission is to provide solutions that enable healthcare providers to improve outcomes and enhance patient and provider safety. Headquartered in Limerick, Pa., Teleflex employs approximately 11,500 people worldwide and serves healthcare providers in more than 130 countries. Additional information about Teleflex can be obtained from the company's website at teleflex.com.
Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
Teleflex, Arrow, Arrow Blue FlexTip, ErgoPack, GlideThru, SecondSite and TaperFree are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. 5/82012 Teleflex Incorporated. All rights reserved. 2012-1091 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).) CONTACT: Teleflex Incorporated Jake Elguicze Treasurer and Vice President Investor Relations 610-948-2836 KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CARDIOLOGY MEDICAL DEVICES FDA SOURCE: Teleflex Incorporated Copyright Business Wire 2012 PUB: 07/02/2012 07:00 AM/DISC: 07/02/2012 07:00 AM http://www.businesswire.com/news/home/20120702005168/