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Teleflex Incorporated (TFX) Receives FDA 510(k) Clearance for ARROW® FlexTip Plus® Closed Tip, Multi-Port Epidural Catheter


5/30/2012 6:57:08 AM

LIMERICK, Pa.--(BUSINESS WIRE)-- Teleflex Incorporated (TFX) announced today the Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The Arrow FlexTip Plus, the market-leading1 Open Tip, Single-Port epidural catheter, has been proven to significantly reduce complications commonly associated with epidural catheters, such as vein cannulations and paresthesia2-3. The Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter has been designed using the same proven technology of the Open Tip, Single-Port catheter, the only coil-reinforced catheter backed by more than a decade of clinical evidence. With the addition of the Closed Tip, Multi-Port catheter, FlexTip Plus now provides the drug dispersion choices clinicians demand.

The coil-reinforced FlexTip Plus catheter material is constructed of polyurethane, while a majority of spring wound catheters are made of nylon. This provides a unique balance of softness and strength which promotes easier insertion, less movement out of the epidural space, better block quality, and higher satisfaction rates. The Closed Tip, Multi-Port catheter provides excellent kink resistance and features a soft, flexible tip with 4 lateral holes.

“Teleflex is adding the FlexTip Plus Closed Tip, Multi-Port to the Arrow catheter family to continue to support physicians with products that address the concerns anesthesiologists face on a daily basis,” said Cary Vance, President, Teleflex Anesthesia and Respiratory. “The FlexTip Plus Closed Tip, Multi-Port is based on proven technology, helping anesthesiologists achieve the drug dispersion they prefer with the quality of care they demand for their patients.”

About Teleflex Incorporated

Teleflex is a leading global provider of specialty medical devices for a range of procedures in critical care and surgery. Our mission is to provide solutions that enable healthcare providers to improve outcomes and enhance patient and provider safety. Headquartered in Limerick, PA, Teleflex employs approximately 11,500 people worldwide and serves healthcare providers in more than 130 countries. Additional information about Teleflex can be obtained from the company's website at 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.

Arrow, FlexTip Plus, and Teleflex are registered trademarks of Teleflex Incorporated or its affiliates. ©2012 Teleflex Incorporated. Lit. No. 2012-0997.

References:

1.

GHX Market Data, FY 2011

2.

Banwell B.R., Morley-Foster P., Krause B.R. Decreased incidence of complications in parturients with the Arrow (FlexTip Plus) epidural catheter. Canadian Journal of Anesthesia. 1998; 45: 370-372.

3.

Junega M., Kargas G.A., Miller D.L. Incidence of epidural vein cannulation in parturients with three different epidural catheters. Regional Anesthesia. 1996; 4: S21.

Contact:

Teleflex Incorporated

Jake Elguicze

Treasurer and Vice President, Investor Relations

610-948-2836



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