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Teleflex (TFX) Announces 510(k) Clearance and US Launch of TrapLiner™ Catheter

WAYNE, Pa.--(BUSINESS WIRE)--

Teleflex Incorporated (TFX), a leading global provider of medical technologies for critical care and surgery, has announced 510(k) clearance by the Food and Drug Administration and US commercial launch of the TrapLiner Catheter.

The TrapLiner Catheter was developed by Vascular Solutions, Inc., which was acquired by Teleflex on February 17, 2017.

The TrapLiner Catheter is similar in design to Vascular Solutions’ popular GuideLiner Guide Extension Catheter, with the added feature of an integrated balloon for trapping a standard 0.014” guidewire within a guide catheter. The TrapLiner Catheter can be used as an alternative method to the trapping technique that requires the use of a PTCA balloon to exchange an existing over-the-wire catheter while maintaining guidewire position. The technique of guidewire trapping for catheter exchange is most commonly performed in complex interventional procedures. The device is offered in three different sizes: 6, 7, and 8 Fr.

“The TrapLiner is a one-of-a-kind product that combines two devices we had previously deployed independently during challenging cases into a single tool that enables the most complicated interventional procedures to be done more efficiently,” said Dimitri Karmpaliotis, MD, PhD, Director of CTO, Complex and High-Risk Angioplasty at Columbia University Medical Center, who was the first to use the device in the United States. “The primary clinical use for the TrapLiner is during cases in which over-the-wire microcatheters are required to cross calcified lesions, navigate bifurcations, or cross tortuous anatomy. During these procedures, the TrapLiner not only provides added backup support and deep-seating for the guide catheter, but also allows the operator to maintain guidewire positioning when exchanging the microcatheter. The distinct two-in-one capability of this device is highly desirable, as it greatly enhances the efficiency of complex procedures.”

The TrapLiner Catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of the guidewire within the vasculature.

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.

GuideLiner and TrapLiner are trademarks or registered trademarks of Vascular Solutions, Inc.

Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2017 Teleflex Incorporated. All rights reserved. MC-003094

Disclaimer: The TrapLiner Catheter CE Mark is pending. This product is not available for sale in the EU.

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