Z-Med II-X - Catheter, valvuloplasty, balloon dilatation

Intended purpose

For Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in patients with isolated pulmonary stenosis and in patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Functional description

The catheters are coaxially constructed with a distally mounted non-compliant balloon. The guidewire is advanced to the desired position and the catheter is passed over the guidewire. An introducer facilitates catheter insertion to position the mid-length of the balloon within the valve. The radiopaque band[s] defines the center/shoulder of the dilatation balloon. The balloon is inflated to achieve dilatation and deflated and withdraw catheter, guidewire and sheath on completion.