Teleflex (TFX) Receives FDA 510(k) Clearance for its Arrow® VPS Rhythm™ Device with Optional TipTracker™ Technology
January 10 2017 - 6:45AM
Business Wire
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
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
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Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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