Assessment of angioplasty balloon catheters: preliminary studies

Gruntzig balloon catheters from three manufacturers have been tested in vitro to establish a method of assessing the diameters and bursting pressures of inflated balloons. The method of testing and of measuring the inflated balloons is described. It was found that there were considerable variations in the behaviour of different balloons, and the relevance of this to arterial rupture is discussed. There were significant associations between the manufacturer and premature rupture of the balloon (p less than 0.01), and between co-axial construction of the catheter and overdistension of the balloon by more than 20% (p less than 0.01). The balloon length and the stated maximum diameter were not associated with either premature failure or overdistension.