Comparison of the diameter consistency and dilating force of the controlled radial expansion balloon catheter to the conventional balloon dilators

OBJECTIVES: Balloon dilation of a luminal narrowing is classically performed with a single-diameter balloon. A new multidiameter balloon that allows three progressively larger, controlled radial expansion diameters of a single-balloon catheter (controlled radial expansion, CRE) has been developed. The purpose of this study was to test the diameter consistency and dilating force at increasing pressure of the CRE balloon-dilating catheter and to compare these features with the conventional balloon-dilating catheters. METHODS: The CRE balloon catheter was compared with the Achiever, Eliminator, and Max Force using in vitro testing to determine their dilating diameters and dilating forces. RESULTS and CONCLUSIONS: This in vitro study has shown that the new CRE balloon catheter with increasing diameter delivers consistently reproducible and progressively greater dilating force. This dilating force of the CRE balloon catheter at its third and maximum diameter inflation was similar to that of the Max Force TTS and significantly greater than that of the conventional balloon dilators, Eliminator and Achiever.