Transit Scientific has received the US Food and Drug Administration (FDA) clearance for its XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform.
The clearance enables the use of the platform in iliac, iliofemoral, popliteal, infra-popliteal and renal arterial, as well as synthetic and native arteriovenous hemodialysis fistula.
The XO Score is a patented, low-profile, flexible, metal-alloy exoskeleton with a balloon-expandable scoring section. It reduces the cost of scoring or cutting procedure.
Expandable polymer balloon catheters are typically used in angioplasty to dilate stenosed or narrowed vessels.
Special scoring or cutting angioplasty balloons with integrated wires or blades on the balloon are required for calcified, fibrous and / or resilient stenosis. The added features improve dilating force while creating large crossing profiles and limited deliverability, which, in turn, increases the cost and inventory.
Transit Scientific’s XO Score sheath can be used with a number of 4mm-8mm diameter and 20mm-40mm long balloons to save the money on each scoring or cutting procedure.
Transit Scientific president Greg Method said: “XO Score transforms regular PTA balloons into scoring and cutting systems.
“Clinicians insert an off-the-shelf PTA balloon into the XO Score tableside and then the system can be used over-the-wire to dilate calcified plaque and prep vessels.”
While typical scoring / cutting balloons feature 1-5 fixed-depth scoring wires / blades that add bulk, profile and stiffness, XO Score has up to 22 scoring / cutting struts that lay flat during tracking.
It rotates 90° during balloon inflation to score and cuts 0.25mm, 0.35mm, or 0.50mm deep and rotates back during deflation.
Last month, Transit Scientific obtained FDA clearance for the XO Cross 2Fr, 2.6Fr and 3.8Fr low-profile microcatheter platform.