According to a press release, Transit Scientific’s XO Score system has been successfully used to dilate multiple challenging fibrotic and calcific lesions in haemodialysis patients with stenotic and occluded fistulas. Richard Saxon (Tri City Medical Center Medical Center, Oceanside, USA) performed the first procedures using the XO Score. Treatment of all the lesions proved successful.
“The XO device performed well and demonstrated effective lesion dilatation at low pressures with a variety of our standard angioplasty balloons,” said Saxon. “The rotating scoring struts appeared to be effective against a mix of fibrous and calcified lesions which tend to be highly resistant to plain old angioplasty.”
Specialty scoring and cutting angioplasty balloons are manufactured with integrated struts, wires, or blades to reduce vessel dissection, dilation pressure, and assist with vessel preparation for atherectomy and/or stenting. However, scoring and cutting balloons also add profile, bulk, expense, inventory, and complexity.
The XO Score is different, a press release states, detailing that XO Score technology allows users to convert basic angioplasty balloons in the hospital’s existing inventory into sophisticated scoring, cutting, and infusion/delivery devices.
“One of the procedures required five separate inflations at various points along the native fistula and outflow vein, all of which were accomplished using the same XO Score device,” continued Saxon. “The ability to achieve a more predictable result at a lower and potentially safer pressure in resistant lesions could prove important in achieving the best possible PTA outcomes and thereby help in fistula maintenance. The fact that you can take quick angiograms through the XO Score and around the PTA balloon was a nice additional feature.”
During an XO Score procedure, clinicians insert a basic angioplasty balloon into the ultra-thin XO Score sheath and advance the combined balloon and XO sheath to the stenosis. When the balloon is inflated, up to 22 evenly spaced XO Score struts expand with the balloon and rotate 900 to score and cut the narrowed vessel. When the balloon is deflated, the struts rotate 900 back to an atraumatic position to assist balloon rewrap and removal.
“We are thrilled to see the XO Score contribute to patient care,” said Greg Method, president and CEO of Transit Scientific. “These procedures demonstrate XO Score effectiveness against a variety of lesion types. We look forward to growing the platform to treat complex peripheral arterial disease (PAD), critical limb ischaemia (CLI), along with haemodialysis access patients.”
The XO Score system has been cleared by the US Food and Drug Administration (FDA) 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.