Device Dossier

Visions PV .035 Digital IVUS Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use

Device Dossier for Visions PV .035 Digital IVUS Catheter - Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular, single-use…

Intended purpose

Intended for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. It is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

Functional description

An over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.89-0.97mm guide wires.

TGA Public Summary