This PTCA catheter balloon is used for dilatation of stenoses in the coronary vessel system.

The catheter balloon is designed according to a rapid exchange system, which ensures the easy use of the product, while combined with the especially designed soft introduction tip offers an extremely low profile (2.5 F on 2.0/2.25 mm; 2.7 F on 2.5–4.0 mm). The result is the easy penetration and push ability of the catheter balloon and the rapid deflation of the balloon by the dilatation material during negative pressure exercise.

The balloon material offers high duration (Rated Burst Inflation Pressure: 16 atm) in order to reach high pressures without bursting, while it eliminates the risk of endothelium dissection or damage.

The typical structure of the catheter (dd: Diameter, ll: Length) appears at the following figure:

The product consists of a double-lumen fast exchange catheter with a mounted balloon from nylon polymer material and a hypo-tube.

At a nominal pressure of 6 bar=0.6 Mpa the balloon reaches its nominal diameter. If the actual pressure is lower or higher than the nominal pressure, the balloon diameter changes. The first lumen that starts distally (21 cm long) is provided for the introduction of a guide wire (0.014"), with an exit at the end of the balloon catheter. The second lumen with the Luer-type connection is used for the inflation and deflation of the balloon.

The usable catheter length is 140 cm.

In addition, the balloon has two radiopaque markers at its edges. Specifically, there is a proximal and a distal X-ray marker (platinum and iridium ring) that define the balloon length (cylindrical part) and allow the correct positioning within the stenosis under X-ray control.

The balloon is compatible with the guide wires (4.5 F width) and is manufactured from high quality semi-compliant material, so when expanded it will match exactly the size of the artery and the size of the lesion. Its manufacturing material is also thermo sensitive, thus making the product highly flexible.

The balloon diameter, according to the given pressure appears at the table below:The balloon diameter, according to the given pressure appears at the table below:

The table of compliance data above appears at the following diagram:

The ALEX PTCA catheter balloons are enclosed in a sterile and single-use packaging. They contain user instructions, balloon-size sticker labels, the reference and LOT number for easier product tracking.

The ALEX PTCA catheter balloon is available in the sizes below:

There is also the possibility of producing different lengths and diameters by order.