WAYNE, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Teleflex Incorporated (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 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®, Hudson RCI®, LMA®, Pilling®, Rusch®, UroLift®, and Weck® – trusted brands united by a common sense of purpose.
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, and Wattson are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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