Device Category Dossier

Catheter, valvuloplasty, balloon dilatation

Device Category Dossier for Catheter, valvuloplasty, balloon dilatation. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Balloon valvuloplasty catheters are devices used to perform percutaneous transluminal balloon valvuloplasty, a procedure that dilates stenotic heart valves. These catheters are employed in the treatment of aortic valve stenosis, particularly in patients awaiting surgical valve correction, those with severe symptomatic stenosis, patients requiring urgent non-cardiac surgery, those ineligible for valve replacement surgery due to comorbidities, and children or adolescents where the procedure can postpone surgical intervention for several years.