USA..Teleflex (TFX) Announces 510(k) Clearance and U.S. Launch of SpectreTM Guidewire

Tuesday, 14 March 2017


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

WAYNE, Pa.--(BUSINESS WIRE)--Mar. 14, 2017-- 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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Source: Teleflex Incorporated

Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836

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Last Updated ( Tuesday, 14 March 2017 )