Transit Scientific (Park City, Utah) today announced that its XO Score percutaneous transluminal angioplasty scoring catheter was successfully used to dilate multiple challenging fibrotic and calcific lesions in hemodialysis patients with stenotic and occluded fistulas.
The FDA granted the catheter 510(k) clearance in May to dilate stenotic material in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
XO Score technology allows users to convert basic angioplasty balloons in the hospital’s existing inventory into scoring, cutting and infusion/delivery devices, according to Transit Scientific.
Dr. Richard Saxon of the SDI Medical Group performed the first procedures using the XO Score at Tri City Medical Center in Oceanside, Calif., and reported that 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,” Saxon said in a news release. “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.”
Percutaneous transluminal angioplasty (PTA) balloons are used millions of times-per-year to dilate narrowed, or stenosed, arteries and veins. During an XO Score procedure, clinicians insert a basic angioplasty balloon into the 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 90 degrees to score and cut the narrowed vessel. When the balloon is deflated, the struts rotate 90 degrees back to an atraumatic position to assist balloon rewrap and removal, according to the company
“We are thrilled to see the XO Score contribute to patient care,” said Transit Scientific president & CEO Greg Method. “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 ischemia (CLI), along with hemodialysis access patients.”