Transit Scientific had shared via press release successful outcomes on multiple fistula and graft cases using its XO Score sheath platform, a first-of-its-kind metal-alloy scoring, cutting, and constraining structure (CS) device, along with off-the-shelf percutaneous transluminal angioplasty (PTA) balloons.
XO Score can be used in significant chronic dialysis fistula and graft cases using low-pressure inflation, in some cases after high-pressure PTA treatment failed.
“A patient presented with a high-grade stenotic lesion in a brachiocephalic fistula restricting 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 and followed by effacement of the stenosis with standard balloon PTA inflated to nominal pressure (nine atmospheres). There was no residual stenosis and the fistula was no longer pulsatile on exam,” Jeffrey Hoggard, an interventional nephrologist at Raleigh Access Center (Raleigh, USA), shared. “XO Score presented a great treatment option for us where high-pressure PTA failed.”
Traditional PTA cutting, scoring, and constraining structure (CS) technologies are manufactured with metal or polymer wires, struts, blades, or grooves wrapped around, or fused to, the outside of the angioplasty balloon. These wires, struts, blades and/or grooves expand with the balloon to provide focal force in calcified, hyperplastic, and/or resistant lesions to prevent dissection, dilate resistant lesions, and/or prep the vessel for other intervention. Traditional systems can be bulky, difficult to use, cost-prohibitive, and require significant inventory.
The XO Score is a thin one-piece metal alloy exoskeleton sheath, with up to 22 struts/grooves, that slides over off-the-shelf 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° back to an atraumatic position and the XO structure assists in balloon rewrap for removal.
XO’s technology can also be optimised to constrain balloons and prevent torsional and longitudinal shear during angioplasty balloon inflation.
The XO Score system is US Food and Drug Administration (FDA) and CE-Mark cleared to dilate stenotic material in iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.