New stent delivery balloon: a technical note.

Abstract

This study reports the first clinical application of a new noncompliant balloon composed of a middle polyurethane layer sandwiched between an inner layer of polyethylene terephtalate and an outer membrane that provides for consistent even expansion. With this balloon design, the very low compliance and high pressure resistance of polyethylene terephthalate are associated with the high elasticity of polyurethane, preventing balloon damage from stent crimping and expansion and allowing a firm embedding of the stent struts. Palmaz-Schatz stent implantation was successful in 33/35 stents (94%), and the two stents that could not be advanced up to the lesion were successfully withdrawn. High pressure expansion of the stent was obtained during deployment with no balloon ruptures at inflation pressures equal or lower than 16 atmospheres (atm). Accurate positioning of the stent was facilitated by the two markers at the balloon ends and by the optimal visualization after contrast injection, even with 6 Fr guiding catheters. This new delivery system maintains the advantages of hand-crimped stents on noncompliant balloons, reducing the risk of stent loss.