Teleflex Receives FDA Clearance for ARROW® Peripherally Inserted Central Catheter (PICC) Preloaded with ARROW® VPS® Vascular Positioning System® Stylet
LIMERICK, Pa.--(BUSINESS WIRE)--Sep 13, 2012--Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its pressure injectable ARROW ® PICC preloaded with the ARROW ® VPS ® Vascular Positioning System ® Stylet. The ARROW VPS replaces the need for confirmatory chest X-ray in the presence of a stable Blue Bullseye by using state-of-the-art, real-time intravascular Doppler, ECG and advanced algorithmic logic to notify the clinician that the catheter tip has reached the optimal location. The preloaded option improves clinician ease of use for vascular navigation and catheter tip positioning.
“We are dedicated to providing technologies for clinicians who strive to make zero complications in vascular care a reality,” said Paul Molloy, President, Vascular Division of Teleflex. “Providing clinicians with the ARROW VPS Stylet preloaded into the ARROW PICC is one of a series of new product introductions that demonstrates our continuous commitment to reducing vascular access complications and improving ease of use for clinicians.” From a workflow perspective, the preloaded ARROW PICC benefits clinicians by saving the time and process of loading the ARROW VPS Stylet into the catheter. Clinically, the ARROW VPS confirms accurate catheter tip position in the lower 1/3 of the SVC-Cavo-Atrial Junction, which has been proven to reduce complications such as thrombosis. 1 The ARROW PICC features a TaperFree ™ body designed to ensure consistent French size along the entire length of the catheter. 2, 3 In accordance with national recommended guidelines, the ARROW PICC powered by ARROW VPS Stylet will be available in an ergonomically-designed, sharps safety, maximal barrier kit that reduces the risk of infection and accidental needle sticks at insertion. Additional information may be found at www.arrowintl.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 11,200 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, the Blue Bullseye symbol, TaperFree, Vascular Positioning System and VPS are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. ©2012 Teleflex Incorporated. All rights reserved. 2012-1211. References: 1. Cadman, A., Lawrance, J., Fitzsimmons, L., Spencer-Shaw, A., & Swindell, R. (2004). To clot or not to clot? That is the question in central venous catheters. Clinical Radiology 59, 349–355.
2. Trerotola, S, Stavropoulos, S, Mondschein, J, et al. Triple-lumen peripherally inserted central catheter in patients in the critical care unit: prospective evaluation. Radiology 2010;256(1):312-330.
3. Nifong TP and McDevitt TJ. The effect of catheter to vein ratio on blood flow rates in a simulated model of peripherally inserted central venous catheters. Chest 2011;140;48-53.
CONTACT: Teleflex Incorporated Jake Elguicze Treasurer and Vice President, Investor Relations 610-948-2836 KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA INDUSTRY KEYWORD: SURGERY HEALTH MEDICAL DEVICES FDA MEDICAL SUPPLIES SOURCE: Teleflex Incorporated Copyright Business Wire 2012 PUB: 09/13/2012 07:00 AM/DISC: 09/13/2012 07:00 AM http://www.businesswire.com/news/home/20120913005151/