Balloon dilation is currently performed with a balloon of a fixed diameter. A new, multi-diameter balloon technology allows three distinct, progressively larger diameters of a single balloon catheter. The purpose of this in-vitro study was to compare the dilating force of the new CRE™ balloon to Achiever™, Eliminator™ and Max Force TTS™ conventional dilators. METHODS: The CRE™ were catheters # 1 with 6, 7, 8 mm diameter, catheter # 2 with 8, 9, 10 mm, catheter # 3 with 10, 11, 12 mm, catheter # 4 with 12, 13, 15 mm and catheter # 5 with 15, 16.5 and 18 mm. The diameter sizes of single conventional diameter dilators were 6, 8, 10, 12, 15 and 18 mm. All balloon dilators were placed in a water bath at body temperature for one minute. The conventional dilators were then inflated to manufacturer's suggested pressure (MSP) within a fixed narrowing 2 mm, 4mm and 5mm smaller than its labeled maximum diameter. The CRE™ catheter was also inflated to MSP associated with each of the three diameters within a fixed metal narrowing 2 mm smaller than its smallest diameter. At the CRE™ maximum diameter, the narrowing it was placed within was 4mm smaller for catheters Nos. 1, 2 and 3, and 5mm smaller for catheters Nos. 4 and 5. RESULTS: Balloon Brand 2mm Narrowing Up to 5mm Narrowing Ibs Std. Dev. Ibs Std. Dev. CRE™ 12.5 3.1 38.2 6.4 Achiever™ 10.9 0.8 12.1 1.9 Eliminator™ 28.3 3.5 26.6 4.4 MaxForce TTS™ 34.5 7.0 319 8.0 CONCLUSIONS: CRE™, at its first and smallest diameter within a 2 mm narrowing, delivered less dilating force than Eliminator™ and MaxForce TTS™. However, at its third and largest diameter, CRE™ delivered significantly greater average dilating force, than the Achiever™ and Eliminator™ (<P 0.05), and similar to the MaxForce TTS™. Further research must be done to determine the effect of dilating force and Controlled Radial Expansion on clinical outcomes. SUMMARY: CRE™ with increasing diameter delivers increasing dilation force which is significantly greater than the Achiever™, Eliminator™ and equal to the MaxForce™ at comparable diameters.
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging