Teleflex Receives FDA Clearance for Wattson™ Temporary Pacing Guidewire
January 22 2020 - 6:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies for critical care and surgery, today announced
that it received 510(k) clearance from the U.S. Food and Drug
Administration for the WattsonTM Temporary Pacing Guidewire – the
first commercially available bipolar temporary pacing guidewire
designed specifically for use during transcatheter aortic valve
replacement (TAVR) and balloon aortic valvuloplasty (BAV).
This innovative device offers clinicians a
0.035” pigtailed guidewire that supports valve delivery and allows
simultaneous intraventricular bipolar pacing during TAVR or BAV
procedures. WattsonTM Temporary Pacing Guidewire is designed to
simplify and shorten TAVR procedures by eliminating the need for
routine use of central venous access and transvenous temporary
pacing catheters.
The WattsonTM Temporary Pacing Guidewire
offers:
- Guidewire support with bipolar pacing capabilities all in one
device
- A multiple electrode configuration and bipolar design,
engineered to inspire confidence in capture during rapid
pacing
- A procedural alternative designed to help avoid a range of
complications associated with traditional right ventricular rapid
pacing
“FDA 510(k) clearance is another important
milestone for the WattsonTM Temporary Pacing Guidewire and for our
Interventional business,” said Matt Anderson, President and General
Manager of the Interventional business unit of Teleflex. “This
innovative device allows us to provide a cutting-edge tool designed
to help clinicians improve patient outcomes by addressing a
previously unmet clinical need during TAVR and BAV procedures.”
Teleflex currently plans to commence a limited
market release of the device in the U.S. during the first quarter
of 2020.
About Teleflex
IncorporatedTeleflex 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 access, interventional cardiology and
radiology, anesthesia, emergency medicine, surgical, urology 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®, UroLift®, and Weck® – trusted
brands united by a common sense of purpose.
Forward-Looking StatementsAny
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, and Wattson are
trademarks or registered trademarks of Teleflex Incorporated or its
affiliates, in the U.S. and/or other countries. © 2020 Teleflex
Incorporated. All rights reserved. MC-006162
Source: Teleflex
IncorporatedJake ElguiczeTreasurer and Vice President, Investor
Relations610-948-2836
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