Teleflex (TFX) Announces 510(k) Clearance and US Launch of TrapLiner™ Catheter
February 22 2017 - 6:00PM
Business Wire
Unique specialty catheter designed for enhancing efficiency in
complex interventional procedures – builds on Vascular Solutions’
popular GuideLiner® Catheter platform by combining the features of
a guide extension catheter with new guidewire trapping capabilities
in a single device.
Teleflex Incorporated (NYSE: 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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Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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