Device Dossier

Comet II Pressure Guidewire - Intravascular haemodynamic monitoring system guidewire

Device Dossier for Comet II Pressure Guidewire - Intravascular haemodynamic monitoring system guidewire (Intravascular haemodynamic monitoring system…

Intended purpose

The Comet II Pressure Guidewire measures blood pressure gradient across coronary lesions during endovascular procedures. The Comet II Pressure Guidewire may also be used as a coronary guidewire for interventional treatments. The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary blood vessels.

Functional description

The Device is a single use, hydrophilic-coated, steerable wire with a custom optical cable. A pressure sensor is mounted approximately 3 cm from the distal end of the radiopaque and shapeable straight tip. There is a hydrophobic coating on the proximal end, and hydrophilic coating on the distal end and tip to facilitate lubricity and guidewire performance.

TGA Public Summary