Effects of focused force angioplasty: pre-clinical experience and clinical confirmation

Balloon angioplasty results in a combination of plaque compression and fracture, creation of intimal flaps and localized medial dissection, as well as the stretching and remodeling of the arterial wall. The application of eccentric pressure to the vessel wall allows for the balloon force to be focused along a specified line resulting in a reduction in vessel resistance with an improved or equivalent result at a lower pressure. The FX miniRAIL is a novel balloon angioplasty catheter that has two external wires that are compressed by the inflating balloon into the vessel wall. It was tested in comparison to conventional balloon injury in a porcine coronary model. At equivalent balloon artery ratios no increase in the length of dissections occurred, but a characteristic longitudinal "cut" was noted in the presence of the FX miniRAIL. A similar finding was demonstrated in sample human cases when interrogated by IVUS and OCT.