Device Dossier

Pressure wire X Guidewire - Intravascular haemodynamic monitoring system guidewire

Device Dossier for Pressure wire X Guidewire - Intravascular haemodynamic monitoring system guidewire (Intravascular haemodynamic monitoring system…

Intended purpose

The PressureWire™ X Guidewire is indicated to measure pressure and temperature in the coronary vasculature to assess patients with coronary artery disease. The PressureWire™ X Guidewire and compatible interconnecting devices are indicated to assess vascular physiological function by measuring physiological indices such as Fractional Flow Reserve (FFR) and Resting Full-Cycle Ratio (RFR).

TGA Public Summary