Device Dossier

VivoHeart Intravascular Ultrasound Imaging System - Ultrasound system, imaging, cardiovascular

Device Dossier for VivoHeart Intravascular Ultrasound Imaging System - Ultrasound system, imaging, cardiovascular (Ultrasound system, imaging,…

Intended purpose

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

TGA Public Summary