Teleflex subsidiary VasoNova has received the US Food and Drug Administration (FDA) 510(k) clearance to market its vascular positioning system (VPS) peripherally inserted central catheter tip location technology.
The technology is marketed as an alternative to chest x-ray or fluoroscopy in adult patients when the guidance indicator shows a blue bull’s eye.
VasoNova VPS system uses a combination of hemodynamic and other biometric data to calculate precise tip location and to communicate the position to the user via a simple graphical interface.
The system provides the clinician with the opportunity to place the catheter correctly, avoiding the need for confirmatory chest x-ray where indicated.
VasoNova said the VPS system, comprising a portable console and a single-use bio-sensor, is compatible with all major makes of central venous catheters.
Teleflex chairman, president and CEO Benson Smith said VasoNova’s VPS system is a central venous catheter navigation technology.
"This clearance puts us in a strong competitive position and offers the potential to establish a new standard of care in catheter placement," Smith said.