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,…
- GMDN category: Catheter, valvuloplasty, balloon dilatation
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.