Teleflex Announces the Limited Market Release of the Wattson™ Temporary Pacing Guidewire

Rhea-AI Summary

Teleflex Incorporated has announced the market release of the Wattson™ Temporary Pacing Guidewire, expanding its structural heart portfolio. The device offers dual functionality, supporting valve delivery and ventricular pacing during procedures like TAVR and BAV. Designed to reduce complications, costs, and procedural steps associated with traditional pacing methods, the guidewire aims to enhance procedural efficiency and safety.

Positive

• Expansion of Teleflex's structural heart portfolio with the market release of the Wattson™ Temporary Pacing Guidewire
• Dual functionality of the device supporting valve delivery and ventricular pacing during structural heart procedures like TAVR and BAV
• Simple design to create procedural efficiencies and reduce complications, costs, and procedural steps associated with traditional pacing methods
• Approval from the FDA for the Wattson™ Temporary Pacing Guidewire in May of 2023

Negative

• None.

Company expands structural heart portfolio and begins the limited market release of a bipolar temporary pacing guidewire intended to introduce and position catheters and other interventional devices within the chambers of the heart while transmitting an electrical signal from an external pulse generator to the heart

WAYNE, Pa., April 30, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the Wattson™ Temporary Pacing Guidewire limited market release has commenced at Columbia University Irving Medical Center. The first cases were performed by Dr. Tamim Nazif, Director of Clinical Research, Dr. Susheel Kodali, Professor of Medicine and Director of the Structural Heart and Valve Center, and Dr. Isaac George, Surgical Director of the Heart Valve Center.

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 structural heart procedures, including transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). The device offers a procedural alternative designed to avoid potential 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.

“We are thrilled that our team at Columbia University Irving Medical Center was selected for the Wattson™ Temporary Pacing Guidewire limited market release and are proud to have completed the first TAVR procedures with this important new device,” said Dr. Tamim Nazif, Director of Clinical Research for Columbia Interventional Cardiovascular Care, Director of the Interventional Cardiology Fellowship Program, and assistant professor in medicine at Columbia University Irving Medical Center. “The Wattson™ Temporary Pacing Guidewire facilitated minimalist TAVR procedures with safe and reliable LV pacing throughout our first two days of cases, and we are eager to continue to use it moving forward.”

Teleflex received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Wattson™ Temporary Pacing Guidewire in May of 2023.

“Providing interventionalists with a new tool specifically engineered to address unmet clinical needs frequently encountered during structural heart procedures is a significant milestone for Teleflex,” said Roger Graham, President and General Manager of the Teleflex Interventional business unit. “The Wattson™ Temporary Pacing Guidewire reflects our steadfast focus on filling gaps in existing technologies as well as our commitment to providing more options that further simplify minimalist TAVR and other structural procedures.”

About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

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, 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. © 2024 Teleflex Incorporated. All rights reserved. MC-009501 Rev 0.

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.

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

investor.relations@teleflex.com
610.948.2836