Teleflex Receives FDA 510(k) Clearance for Nylus™ PICC with Semprus Sustain™ Technology
LIMERICK, Pa.--(BUSINESS WIRE)--Nov 14, 2012--Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced that its Semprus BioSciences subsidiary has been granted 510(k) clearance for the Company’s innovative vascular access catheter, the Nylus™ Peripherally Inserted Central Catheter (PICC) with Semprus Sustain™ Technology. The Nylus PICC is indicated to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The FDA clearance follows the product’s European market clearance in July, 2012.
The Nylus PICC uses a long-lasting polymer surface modification designed to reduce the attachment of platelets and blood proteins at the surface of the medical device. This provides benefits to the patient, the caregiver and the health care system. The Nylus PICC has been shown to reduce platelet adhesion and thrombus accumulation by 99% in both in vitro and acute animal testing. 1 “Teleflex is pleased to obtain FDA clearance for the Nylus PICC, which is the first generation of the Semprus Sustain platform technology to move through the FDA 510(k) process,” said Benson Smith, Chairman, President and CEO of Teleflex Incorporated. “We continue to be excited about the technology’s potential to reduce thrombus-related complications for patients in a variety of applications.” “With both U.S. and European market clearance, we are advancing a new standard of care for PICC catheters, in which improved patient outcomes and lower health care costs creates a win-win situation for patients and the healthcare delivery system,” said David L. Lucchino, VP and co-founder of Semprus BioSciences.
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 11,100 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.
Teleflex, Nylus, Semprus, and Semprus Sustain are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. ©2012 Teleflex Incorporated. 2012-1538 References: 1 In vitro and in vivo data on file.CONTACT: Teleflex Incorporated Jake Elguicze Treasurer and Vice President, Investor Relations 610-948-2836 KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY MEDICAL DEVICES RADIOLOGY FDA MEDICAL SUPPLIES SOURCE: Teleflex Incorporated Copyright Business Wire 2012 PUB: 11/14/2012 05:00 PM/DISC: 11/14/2012 05:00 PM http://www.businesswire.com/news/home/20121114006947/