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# Transit Scientific XO PTA Scoring Sheath Cleared
- URL: https://www.fdaweb.com/transit-scientific-xo-pta-scoring-sheath-cleared/
- Published: 2020-06-05T12:00:00.000Z
- Updated: 2026-09-14T16:17:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146947

FDA has cleared a Transit Scientific 510(k) for its XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic or native arteriovenous hemodialysis fistula procedures. Angioplasty is performed with expandable polymer balloon catheters to dilate stenosed, or narrowed, vessels, the company says. “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.”

The device is described as a 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, the company says. “The low-profile design is smooth for tracking to and from the treatment site,” it says. “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.”

Transit Scientific says that other scoring/cutting balloons feature one to five fixed-depth scoring wires/blades that add bulk, profile, and stiffness. The 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, 0.35mm, or 0.50mm deep.