FDA AND CE MARK CLEARED
VESSEL PREP & TREATMENT
With off-the-shelf PTA balloons
XO Low Profile RX Angioplasty Platform is a novel vessel prep and treatment system that fits over standard off-the-shelf PTA balloons
Dilate calcium & neointimal hyperplasia
Treat resistant lesions at low pressure
Reduce shear & facilitate PTA balloon rewrap
Compatible with a broad range of standard PTA balloon sizes
(1.5-7mm outer diameter & 20-200mm lengths)
Available in both rapid exchange (RX) and over-the-wire (OTW) configurations
THE XO SCORE® SHEATH PLATFORM (OVER THE WIRE)
THE XO SCORE® SHEATH PLATFORM (RAPID EXCHANGE)
Images are not representative of the actual device.
A novel, adaptable, and cost-effective
solution to focal force vessel prep
XO SCORE® SOLUTION
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. Theses 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 interventions. 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 in a hospital’s existing inventory. When the angioplasty balloon is inflated, the struts/grooves expand with the balloon and rotate 90 degrees to apply focal force to the vessel. When the balloon is deflated, the XO struts/grooves rotate 90 degrees back to an atraumatic position and the XO structure assists in balloon rewrapping for removal.
XO’s technology can also be optimized to constrain balloons and prevent torsional and longitudinal shear during angioplasty balloon inflation.
XO SCORE® HISTOLOGY
In previous testing, the XO SCORE® device has been successful in creating uniform, controlled, and circumferential scoring into the vessel wall.
Evidence of multi-focal, circumferential scoring using XO SCORE® D25
Close-up view of micro-fissures from original image
XO SCORE® FLEXIBILITY DEMO
The XO Score® Sheath Platform is FDA 510(k) and CE Mark cleared to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.