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Teleflex Receives FDA Clearance for the Wattson® Temporary Pacing Guidewire

Written by Customer Service on . Posted in Public Companies.

Company expands Structural Heart Portfolio with the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV)

WAYNE, Pa., June 07, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced it will feature the Wattson® Temporary Pacing Guidewire – the first commercially available bipolar temporary pacing guidewire designed specifically for use during TAVR and BAV – at TVT: The Structural Heart Summit, June 7-10 at the Phoenix Convention Center-West.

Featuring a simple design to create procedural efficiencies, the Wattson® Temporary Pacing Guidewire offers dual functionality, supporting both valve delivery and ventricular bipolar pacing during TAVR or BAV procedures. The device offers a procedural alternative designed to help avoid a range of complications1, steps1, and costs2 associated with traditional right ventricular pacing. From its flexible distal pigtail shape to its multiple electrode, bipolar design, the Wattson® Temporary Pacing Guidewire is engineered to help reduce the risk of ventricular perforation while providing confidence in capture during rapid pacing.

“This technology enables us to provide physicians with a new tool specifically engineered to address unmet clinical needs frequently encountered during TAVR or BAV procedures,” said Jake Newman, President of The Americas at Teleflex. “The Wattson® Temporary Pacing Guidewire reflects our focus on purposeful innovation and commitment to providing more options to further simplify minimalist TAVR and other structural procedures.”

The Wattson® Temporary Pacing Guidewire will enter a limited market release phase, with full market release anticipated later this year.

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 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®, LMA®, Pilling®, QuikClot®, Rusch®, UroLift® 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.

References:

  1. Clinical Investigation: TEMPORARY PACING GUIDEWIRE STUDY. Testing completed by Teleflex. Data on file with Teleflex. Bench test results may not necessarily be indicative of clinical performance.
  2. Faurie B, Souteyrand G, Staat P, Godin M, Caussin C, Van Belle E, Mangin L, Meyer P, Dumonteil N, Abdellaoui M, Monségu J, Durand-Zaleski I, Lefèvre T; EASY TAVI Investigators. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459.

CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.

Teleflex, the Teleflex logo, Arrow, Deknatel, GuideLiner, LMA, Pilling, QuikClot, Rusch, UroLift, Wattson, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this document is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. 

© 2023 Teleflex Incorporated. All rights reserved. MC-008983.

Contacts:

For Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development

investor.relations@teleflex.com
610.948.2836

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