Device Dossier

Z-MED II Percutaneous Transluminal Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation

Device Dossier for Z-MED II Percutaneous Transluminal Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty,…

Intended purpose

Percutaneous transluminal valvuloplasty (PTV) of the pulmonary valve, and for mitral and aortic positions.

Functional description

It is a coaxial design catheter with a balloon mounted on its distal tip. The lumen labelled with the balloon size is for balloon inflation while the through lumen allows the catheter to track over a guidewire. A radiopaque band defines the centre (or shoulders if two) of the dilatation balloon. Each balloon inflates to the stated diameter and length at a specific pressure

TGA Public Summary