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Teleflex Receives FDA 510(k) Clearance for Antithrombogenic Claims on its ARROW Peripherally Inserted Central Catheter (PICC) w


Published on 2012-05-21 14:05:46 - Market Wire
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LIMERICK, Pa.--([ ])--Teleflex Incorporated (NYSE:TFX) announced today that in addition to broad-spectrum antimicrobial protection, the pressure-injectable ARROW PICC with Chlorag+ard Technology provides antithrombogenic protection for at least 30 days. Itas the worldas first central venous catheter to significantly reduce the risk of two common complications associated with peripherally inserted central catheters, compared to traditional uncoated PICCs.

"The ARROW PICC with Chlorag+ard technology has demonstrated the ability to protect against infection and now thrombosis for at least 30 days; itas a world first and not available from any other company"

Chlorag+ard 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 reduction1 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 days2
  • When challenged with infection, 92% reduction in thrombus accumulation on catheter surfaces after 30 days2
  • Reduced thrombotic intraluminal occlusion3
  • Reduction in phlebitis and an average of 72% less intimal hyperplasia after 30 days2

aTeleflexas 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 costsfor 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 lines10.

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%4,5, while asymptomatic rates are as high as 38.5%6. Thrombosis has also been shown to have a correlation to bloodstream infection7.

The health economic impact is also significant, with average cost of care for upper extremity vessel thrombosis exceeding $11,0008 per incident and cost of care for CLABSI exceeding $29,0009 per incident.

aThe ARROW PICC with Chlorag+ard technology has demonstrated the ability to protect against infection and now thrombosis for at least 30 days; itas a world first and not available from any other company,a said Paul Molloy, President of Teleflex Vascular Division. aTogether 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.a

In accordance with national recommended guidelines, the ARROW PICC with Chlorag+ard 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.

Additional information may be found at [ www.chloragard.com ].

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. For additional information about Teleflex, please refer to [ http://www.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, VPS and Chlorag+ard are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. All rights reserved.

References:

  1. In vitro data on file
  2. As compared to uncoated PICCs, intravascular ovine model
  3. As compared to uncoated PICCs, evidenced by 51% less pressure to clear thrombus in in vitro model measuring flush pressure post exposure to human blood
  4. Evans SR, Sharp JH, Lorraine LH, et al. Risk of Symptomatic DVT Associated With Peripherally Inserted Central Catheters. CHEST 2010;138;803-810
  5. C.T. COWL, J. V. WEINSTOCK, A.AL-JURF, K. EPHGRAVE, J. A. MURRAY, K.DILLON. Clinical Nutrition (2000) 19(4): 237-243
  6. Abdullah, et al. aIncidence of Upper Limb Venous Thrombosis Associated with PICC.a The British Journal of Radiology, 2005
  7. Timsit JF, et al. Central Vein Catheter-Related Thrombosis in Intensive Care Patients :Incidence, Risks Factors, and Relationship With Catheter-Related Sepsis.Chest 1998;114;207-213
  8. Lissovoy Gd, et al. Cost for Inpatient Care of Venous Thrombosis. Arch Intern Med. 2000;160:3160-3165
  9. emaxhealth.com/1506/39/36125/mrsa-c-diff-and-clabsi-updates-hospital-acquired-infections.html
  10. McKnight S. Nurse's guide to understanding and treating thrombotic occlusion of central vascular access devices. Medsurg Nurs. 2004;13:377-382