Transit Scientific has received US Food and Drug Administration (FDA) clearance for the XO Score percutaneous transluminal angioplasty (PTA) scoring sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula.
Angioplasty is performed with expandable polymer balloon catheters to dilate stenosed, or narrowed, vessels. Calcified, fibrous, and/or resilient stenosis may require special scoring or cutting angioplasty balloons with integrated wires or blades on the balloon. The added features focus and improve dilating force but result in large crossing profiles and limited deliverability while increasing cost and inventory, Transit Scientific said in a press release announcing the regulatory approval.
“XO Score transforms regular PTA balloons into scoring and cutting systems,” said Greg Method, president of Transit Scientific. “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.”
The XO Score is a patented, low-profile, flexible, metal-alloy exoskeleton with a balloon expandable scoring section. One XO Score sheath can be used with a number of 4–8mm diameter and 20–40mm balloons to save the hospital, outpatient lab, ambulatory surgery centre (ASC), or office-based lab (OBL) money on each scoring or cutting procedure.
“XO Score is a new way to prep the vessel,” said Jihad Mustapha, interventional cardiologist, Advanced Cardiac & Vascular Center, (Grand Rapids, USA). “The low-profile design is smooth for tracking to and from the treatment site. But, during balloon inflation, XO Score struts rotate 90 degrees on edge to score and cut. Upon deflation, the XO Score rewraps back-to-flat for smooth withdraw.”
Competitive 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 while tracking but rotate 90 degrees during balloon inflation to score and cut 0.25mm (0.010″), 0.35mm (0.014″), or 0.50mm (0.020″) deep. Struts rotate 90 degrees back during deflation.
This FDA clearance covers the 6.3Fr (French) XO Score in 65cm and 125cm working lengths with 0.25mm (0.010″), 0.35mm (0.014″), or 0.50mm (0.020″) scoring or cutting depths to enable precise dilation across a range of lesion types. Future 3Fr, 4Fr, and 5Fr over-the-wire and rapid-exchange XO Score versions are under development for smaller vessel and coronary use.
In May 2020, Transit Scientific received FDA clearance for the XO Cross 2Fr, 2.6Fr, and 3.8Fr low-profile, high-torque, and high-push non-tapered microcatheter platform. Transit Scientific is a private company with more than 26 combined issued and pending patents to commercialise medical devices including the FDA-cleared XO Score and XO Cross platforms.