Device Dossier

Eagle Eye Platinum ST RX Digital IVUS Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Device Dossier for Eagle Eye Platinum ST RX Digital IVUS Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular,…

Intended purpose

To provide ultrasound images of the coronary vessels and peripheral arteries with measurements of lumen and vessel size, plaque area and the location of key anatomical landmarks.

Functional description

The Eagle Eye Platinum ST RX Digital IVUS Catheters are indicated for use in the evaluation of vascular morphology in coronary vessels and peripheral arteries by providing a cross-sectional image of such vessels. The Eagle Eye Platinum ST RX Digital IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

TGA Public Summary