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Título: Teleflex (TFX) Receives FDA 510(k) Clearance for its Arrow® VPS Rhythm™ Device with Optional TipTracker™ Technology
Fecha: 10-01-2017
Teleflex (TFX) Receives FDA 510(k) Clearance for its Arrow® VPS Rhythm™ Device with Optional TipTracker™ Technology
510(k) Clearance for the Arrow® VPS Rhythm™ Device expands Teleflex’s Catheter Tip Navigation and Placement portfolio to now include familiar ECG-only technology for the elimination of chest X-ray
WAYNE, Pa.--(BUSINESS WIRE)--Jan. 10, 2017-- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced that its Arrow® VPS Rhythm™ Device with Optional TipTracker™ Technology has been issued 510(k) Clearance to commercialize the device in the United States.
The Arrow® VPS Rhythm™ Device is a simple and versatile solution that provides ECG-based tip confirmation in a highly portable and lightweight design.
The Arrow® VPS Rhythm™ Device assists in placement and confirmation of a catheter tip in the SVC-CAJ (superior vena-cava-cavoatrial junction); it may be used with a broad range of catheter types and brands. Intravascular P-wave changes are saved as the catheter approaches the SVC, helping to identify the lower 1/3 of the SVC, near the CAJ, eliminating the need for confirmatory chest X-ray or fluoroscopy in adult patients. When paired with the single-use TipTracker™ Stylet for insertion of peripherally-inserted central catheters (PICCs), the Arrow® VPS Rhythm™ Device provides real-time visual navigation by tracing the catheter pathway with a blue line on a color screen. The Device has an expansive sphere of visual navigation to provide easy navigation of the PICC during insertion.
“This clearance positions us to provide catheter tip placement solutions that meet customer’s unique therapeutic and budgetary needs,” said Jay White, president and general manager, Vascular Division of Teleflex. “The VPS Rhythm™ Device with Optional TipTracker™ Technology will complement our existing Arrow® VPS G4™ Device, diversifying and strengthening our catheter tip positioning portfolio globally. Most importantly, it furthers our goal of making products that simplify clinician’s work and improve a patient's care.”
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck® – trusted brands united by a common sense of purpose.
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, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch, TipTracker, VPS Rhythm and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are trademarks of their respective owners.
© 2017 Teleflex Incorporated. All rights reserved. MC-002962

View source version on businesswire.com: http://www.businesswire.com/news/home/20170110005044/en/
Source: Teleflex Incorporated
Teleflex Incorporated Jake Elguicze Treasurer and Vice President, Investor Relations 610-948-2836
Fuente: endovascular.es

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