Teleflex Inc. Wins FDA Approval of Its Twin-Pass Torque Dual Access Catheter

Dual access catheter enables a 0.014" guidewire to remain in place while delivering contrast, medication, or a second 0.014" guidewire – new Torque version builds on Vascular Solutions’ long-standing Twin-Pass Catheter platform with enhanced torque response and precise angle alignment into side branch vessels

WAYNE, Pa.--(BUSINESS WIRE)--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 both U.S. and international commercial launch of the Twin-Pass Torque Dual Access Catheter.

“guidewire deployed through the RX lumen into the main branch, the OTW lumen can be used for guidewire exchange, subsequent delivery of a second guidewire into a side branch, or fluid injection to a desired distal vessel segment.”

Twin-Pass Dual Access Catheters contain both a rapid-exchange (RX) lumen and an over-the-wire (OTW) lumen. With a 0.014" guidewire deployed through the RX lumen into the main branch, the OTW lumen can be used for guidewire exchange, subsequent delivery of a second guidewire into a side branch, or fluid injection to a desired distal vessel segment.

“The Twin-Pass Torque Catheter builds on Vascular Solutions’ 12-year legacy with our original Twin-Pass Dual Access Catheter, that has been gaining in popularity among interventionalists as the number of complex procedures continues to grow rapidly,” said Chad Kugler, Vice President of Research & Development of the Vascular Solutions division of Teleflex. “This newly-launched version is designed for procedures that call for the delivery of two interventional guidewires from a single catheter in clinical situations where catheter delivery and torsional control are paramount. The new version of the Twin-Pass will allow the physician to achieve precise side-branch access, an important capability in many complex interventions.”

The Twin-Pass Torque Catheter is intended to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement and exchange of guidewires, and to subselectively infuse/deliver diagnostic and therapeutic agents.

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, Twin-Pass, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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