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

Intended purpose

For use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. It is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

Functional description

The device has a cylindrical ultrasound transducer array that radiates acoustic energy. The energy is detected as echoes and generates real-time images of the coronary and peripheral vessels. The internal lumen accommodates a 0.014" guide wire that exits 24 cm proximal to the catheter tip. Three radiopaque markers 1mm long are included in the internal lumen, 10mm apart, with a 10mm tip to imaging distance. This device is used exclusively with Volcano s5 Series and CORE series imaging systems