Device Dossier

TrueVision Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Device Dossier for TrueVision Intravascular Ultrasound Imaging Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular,…

Intended purpose

The TrueVision Intravascular Ultrasound Imaging Catheter is intended to be used for ultrasonic examination of intravascular lesions in coronary arteries to diagnose intra-vascular stenoses. The catheter is used with the VivoHeart Intravascular Ultrasound Imaging System. It is indicated for patients with intra-vascular stenoses requiring transluminal coronary interventional procedures

Functional description

The IVUS System emits electric pulses to stimulate the ultrasonic transducer at the front end of the IVUS Catheter to generate ultrasonic waves. Then the reflected ultrasonic waves will be received by the ultrasonic transducer to convert into electrical signals, which will be delivered to the IVUS System.

TGA Public Summary