“A patient presented with a high-grade stenotic lesion in a brachiocephalic fistula limiting venous outflow. The lesion was resistant to initial treatment using a high pressure PTA inflated to 40 atmospheres. The lesion was then treated with the XO Score device followed by obliteration of the stenosis with a standard PTA balloon inflated to nominal pressure (nine atmospheres). There was no residual stenosis and the fistula was no longer pulsatile on examination,” Jeffrey Hogardinterventional nephrologist at the Raleigh Access Center (Raleigh, USA), shared. “XO Score presented us with an excellent treatment option for high pressure ATP failure.”
ATP’s traditional cut, notch, and stress structure (CS) technologies are made with metal or polymer wires, spacers, blades, or grooves wrapped around or fused to the outside of the balloon of angioplasty. These wires, struts, blades, and/or grooves expand with the balloon to provide focal force into calcified, hyperplastic, and/or resistant lesions to prevent dissection, dilate resistant lesions, and/or prepare the vessel for another action. Traditional systems can be bulky, difficult to use, prohibitively expensive, and require a large inventory.
The XO Score is a thin, one-piece metal alloy exoskeleton sheath, with up to 22 struts/grooves, that slides over standard angioplasty balloons. When the angioplasty balloon is inflated, the struts/grooves expand with the balloon and rotate 90° to apply focal force to the vessel. When the balloon is deflated, the XO struts/grooves rotate 90° to an atraumatic position and the XO structure assists in repacking the balloon for removal.
XO’s technology can also be optimized to constrain balloons and prevent torsional and longitudinal shear during angioplasty balloon inflation.
The XO Score System is US Food and Drug Administration (FDA) cleared and CE marked for dilating stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment obstructive lesions of the native arteries or synthetic arteriovenous dialysis fistula.