Quality Determining Parameters of Balloon Angioplasty Catheters.

The investigations carried out on balloon angioplasty catheters using a parameter test unit allow an objective comparison and a qualitative assessment of catheter brands with respect to their stenosis passability. The design of the test unit allows the measure of other parameters important for clinical practice, such as pushability and trackability. Altogether 8 over-the-wire and 10 monorail-catheters from 7 different manufacturers were investigated by our study. Between modern over-the-wire and monorail systems there exists no fundamental difference in passage capability. In some brands of catheter the stenosis model shows no increase in the amount of thrust required, even after repeated inflation; this is accountable to the good folding properties of the balloon. Angioplasty balloons made of less overstretchable or thinner material yielded the best results. The fact that changes in balloon quality may result from pre-inflation should carry weight in discussions concerning the reuse of catheters. The measurement results are useful for the correct selection of a catheter appropriate to the therapy task at hand.