New Angioplasty System Dilates Calcified and Fibrotic Vessels

November 13, 2020 — The new U.S. Food and Drug Administration (FDA) cleared XO Score system was successfully used to dilate multiple challenging fibrotic and calcific lesions in hemodialysis patients with stenotic and occluded fistulas. Richard Saxon, M.D., FSIR, interventional radiologist and member of the SDI Medical Group, while working at Tri City Medical Center Medical Center, Oceanside, Calif., performed the first procedures using the XO Score. Treatment of all the lesions proved successful.

The XO Score system is FDA cleared 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.  

"The XO device performed well and demonstrated effective lesion dilatation at low pressures with a variety of our standard angioplasty balloons," said Richard Saxon, M.D. "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. Hospitals typically stock hundreds of different angioplasty balloons diameters and lengths to cover diverse patient needs. Calcified and/or fibrous vessels are difficult to dilate and often require high-pressure and/or scoring & cutting systems. 

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 & cutting balloons also add profile, bulk, expense, inventory, and complexity.   

The FDA-Cleared XO Score is different. 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," Saxon explained. "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 ischemia (CLI), along with hemodialysis access patients."  

Transit Scientific designs, develops, and commercializes medical devices including the FDA-cleared XO Score scoring sheath and  XO Cross microcatheters.  XO Cross 0.014 and 0.035 microcatheters were launched Fall 2020. The XO Score and XO Cross platform is protected by 25+ combined issued and pending global patents.   

For more information: www.XOScore.com