Teleflex (TFX) Announces 510(k) Clearance and U.S. Launch of Spectre™ Guidewire
March 14 2017 - 6:30AM
Business Wire
Competitively-priced 0.014" workhorse guidewire
designed for premium performance in coronary and peripheral
interventions – stainless steel-nitinol core wires available in 190
cm and 300 cm lengths – with enhanced trackability and torque
control
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 U.S.
commercial launch of the Spectre Guidewire.
The Spectre Guidewire is engineered with a smooth stainless
steel-to-nitinol dual-core transition that balances strength and
agility. It’s a 0.014" guidewire available in 190 cm and 300 cm
lengths with a distal hydrophilic coating and a proximal PTFE
coating.
Approximately 70% of guidewires used in percutaneous coronary
interventions (PCIs) are considered workhorse wires and are used to
deliver catheters, balloons, stents, and other diagnostic and
therapeutic devices. As a workhorse wire, the Spectre Guidewire was
designed to be applicable to the majority of PCIs.
“We are excited to enter the large market for mainstream
guidewires with the introduction of Spectre, which offers high-end
performance characteristics at competitive prices in response to
the demands of our physician customers for more guidewire options,”
said Chad Kugler, Vice President of Research & Development of
the Vascular Solutions division of Teleflex. “Vascular Solutions
designed Spectre with a proximal stainless steel core that combines
pushability with support for optimal delivery and a distal nitinol
core that is highly flexible and kink-resistant for increased
durability. We believe this design offers an excellent combination
of trackability and torque control.”
The Spectre Guidewire is intended for use in percutaneous
procedures to introduce and position catheters and other
interventional devices within the coronary and/or peripheral
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.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA,
Pilling, Rusch, Spectre, 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-003147
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Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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