US FDA grants 510(k) clearance to Teleflex for Arrow VPS Rhythm devices

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Teleflex’ Arrow vascular positioning system

Teleflex’ Arrow Vascular positioning system (VPS) Rhythm device with optional TipTracker technology has been issued 510(k) clearance from the US Food and Drug Administration (FDA) to commercialise the device in the USA.

According to a company release, the Arrow VPS Rhythm device provides ECG-based tip confirmation in a portable and lightweight design.

The device is designed to assist in placement and confirmation of a catheter tip in the superior vena-cava-cavoatrial junction. It may be used with a broad range of catheter types and brands. Intravascular P-wave changes are saved as the catheter approaches the superior vena cava, helping to identify the lower 1/3 of the superior vena cava, near the cavoatrial junction, eliminating the need for confirmatory chest X-ray or fluoroscopy in adult patients.

When paired with the single-use TipTracker stylet for insertion of peripherally-inserted central catheters, the Arrow VPS Rhythm device is designed to provide real-time visual navigation by tracing the catheter pathway with a blue line on a colour screen. The device has an expansive sphere of visual navigation to provide easy navigation of the peripherally-inserted central catheter during insertion.