FDA Clears the XO Score® Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform

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Transit Scientific notes: 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.

XO Score transforms regular PTA balloons into scoring and cutting systems,” said Greg Method, President, Transit Scientific, Park City, Utah. “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 long balloons to save the hospital, outpatient lab, ambulatory surgery center (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, MD Interventional Cardiologist, Advanced Cardiac & Vascular Center, Grand Rapids, MI. “The low-profile design is smooth for tracking to and from the treatment site. But, during balloon inflation, XO Score struts rotate 90° 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° during balloon inflation to score and cut 0.25mm (0.010″), 0.35mm (0.014″), or 0.50mm (0.020″) deep. Struts rotate 90° back during deflation.

“XO Score adds new technology and value to angioplasty,” continued Mr. Method. “Rotating struts allow clinicians to vary scoring depth without increasing device profile. Economically, XO Score offers a direct value proposition: (1) XO Score + (1) off-the-shelf PTA balloon will cost less than (1) specialty PTA scoring or cutting technology.”

This FDA clearance covers the 6.3Fr (French) XO Score in 65cm & 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 commercialize medical devices including the FDA cleared XO Score® and XO Cross® platforms.

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