Teleflex Receives FDA 510(k) Clearance for Next Generation Vascular Positioning System®
LIMERICK, Pa.--(BUSINESS WIRE)--Apr 29, 2013--Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, announces that its ARROW ® VPS G4 ™ Device has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA). The ARROW VPS G4 Device is used in conjunction with the accompanying disposable ARROW ® VPS ® Stylet and will be available in the US in Q2, 2013.
The ARROW VPS Device is the only system to use micro-Doppler ultrasound technology in combination with intravascular ECG and advanced algorithms to locate the exact location of the lower 1/3 of the superior vena cava and cavo-atrial junction – the ideal location for the tip of a PICC. The technology is designed to provide clinicians real time information, which can enable avoidance of potentially serious clinical complications such as thrombosis, arterial puncture and vessel wall damage.
The new ARROW VPS G4 Device offers state-of-the-art design and technology, providing easy-to-follow symbols with further enhancements such as statement of final catheter position, improved sterile field capability, and Wi-Fi access to enable integration with hospital data management systems.
“There are more than three million PICCs and two million CVCs placed in the United States each year,” states Paul Molloy, President of the Vascular Division. “The ARROW VPS G4 Device is a reliable and easy-to-use system designed to help reduce complications and reduce patient exposure to radiation. If used on a regular basis, the system can help streamline hospital workflow, providing benefits to the patient, the caregiver and the health care system. This new product introduction complements our full portfolio aimed at making zero complications in vascular access a reality.”
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 11,600 people worldwide and serves healthcare providers in more than 140 countries. Additional information about Teleflex can be obtained from the company's website at teleflex.com.