Device Dossier

PressureWire™ X Guidewire (Wireless Connection) - Intravascular haemodynamic monitoring system guidewire

Device Dossier for PressureWire™ X Guidewire (Wireless Connection) - Intravascular haemodynamic monitoring system guidewire (Intravascular haemodynamic…

Intended purpose

The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of any physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).

Functional description

The PressureWire X guidewire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements of physiological parameters. The guidewire is uniquely paired with a specific transmitter. It is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature

TGA Public Summary