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Continued Clinical Success Reported with Unique Cutting-Edge Vessel Prep Device

Friday, July 01, 2022

Transit Scientific shares successful outcomes on multiple fistula and graft cases using its XO Score Sheath Platform along with off-the-shelf percutaneous transluminal angioplasty (PTA) balloons.

XO Score has been instrumental 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 (ATM). 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 (9 ATM). There was no residual stenosis and the fistula was no longer pulsatile on exam." shared Dr. Jeffrey Hoggard, Interventional Nephrologist at Raleigh Access Center in Raleigh, North Carolina. "XO Score presented a great treatment option for us where high-pressure PTA failed."

Another recent case involved a PTA-resistant lesion in a brachiobasilic graft with flow-restricting outflow stenosis. The lesion failed to respond to a PTA inflated to 22 ATM. Initial treatment was followed up with XO Score over a standard off-the-shelf PTA balloon inflated to nominal pressure (12 ATM). The flow was restored and no residual stenosis or elastic recoil was present.

Angioplasty is traditionally used to dilate stenosed, or narrowed dialysis fistulas and grafts to prolong use. Fistulas and grafts with challenging calcific lesions can be especially difficult to treat and are prone to complications, such as recoil and dissection. Unsuccessful treatment and complications can lead to the early failure of fistulas and grafts.

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 are 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 optimized to constrain balloons and prevent torsional and longitudinal shear during angioplasty balloon inflation.

Dr. Richard Saxon of Tri-City Medical Center in San Diego, California shared, "I recently noted impressive results

using XO Score in a critical recurrent brachiocephalic outflow stenosis and moderate central arch stenosis. The XO Score crossed both lesions without difficulty, and allowed for a 5mm and 6mm PTA to be used for effective lesion dilatation with no evidence of post-treatment recoil." Dr. Saxon added, "XO Score introduces a new treatment option to help restore and maintain patency in arteriovenous fistulas and grafts in hemodialysis patients."

The XO Score system is FDA and CE-Mark 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.

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