Device Dossier

Balton Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation

Device Dossier for Balton Valvuloplasty Catheter - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty, balloon dilatation, Class III,…

Intended purpose

Device is indicated for Percutanous Transluminnal Balloon Valvuloplasty (PTV) in treatment of aortic valve stenosis. The procedure has quite limited indications, which include: 1. situations, in which the patient is prepared for surgical valve correction, but his/her condition requires immediate intervention; 2. severe symptomatic aortic stenosis; 3. events, in which the patient with aortic stenosis requires urgent not heart-related surgery; 4. patients, with critical aortic stenosis, but in view of co-existing charges are not eligible for heart valve replacement surgery; 5. in children and youth – allows for postponement of surgical correction for a period from few to several years.

Functional description

The Balton Valvuloplasty Catheter consists of a flexible, balloon-tipped tube used for the plastic or restorative surgery of a cardiac valve. The device's intended use is achieved through the placement of the catheter across the stenotic cardiac valve and inflating the balloon tip.

TGA Public Summary