Niki Arrowsmith05.01.13
Limerick, Pa.-based Teleflex Inc., maker of critical care and surgical devices, has obtains 510(k) clearance from the U.S. Food and Drug Administration for its Arrow VPS G4 device. The device is designed for use in conjunction with the disposable ArrowVPS stylet and will be available in the United States in the second quarter of this year.
Arrow VPS G4 is designed to track and pinpoint the exact location of the lower third of the superior vena cava and cavo-atrial junction, which is the ideal location for the tip of a peripherally inserted central catheter (PICC). The technology is designed to provide clinicians real-time information, which helps avoid potentially serious clinical complications such as thrombosis, arterial puncture and vessel wall damage. The system uses micro-Doppler technology with intravascular electrocardiogram to function.
The device is provided with directions in the form of symbols, and confirms when the catheter is in its final intended position. According to the company, the new system also has an improved sterile field capability, and Wi-Fi access to enable integration with hospital data management systems.
PICC lines, which usually are inserted for use during a long length of time (weeks or months, sometimes years), are used for a variety of reasons, including intravenous delivery of parenteral nutrition, chemotherapy, antibiotics or other medications.
“There are more than three million PICCs and two million central venous catheters placed in the United States each year,” said Paul Molloy, president of the Teleflex’s 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 healthcare system. This new product introduction complements our full portfolio aimed at making zero complications in vascular access a reality.”