Teleflex Receives FDA 510(k) Clearance for ARROW® FlexTip Plus® Closed Tip, Multi-Port Epidural Catheter
May 30 2012 - 6:00AM
Business Wire
Teleflex Incorporated (NYSE: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.
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