Device Dossier

Tyshak Mini - Catheter, valvuloplasty, balloon dilatation

Device Dossier for Tyshak Mini - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty, balloon dilatation, Class III, sponsor Intervene…

Intended purpose

Percutaneous transluminal valvuplasty of the pulmonary valve in paediatric applications: 1) A patient with isolated pulmonary stenosis, 2) A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

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