News | Balloon Catheter | June 04, 2020

FDA Clears Scoring Sheath That Fits Over Standard Angioplasty Balloons

New metal-alloy sheath converts angioplasty balloons into scoring and cutting systems

Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared 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. This is a new type of scoring balloon technology.

June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared 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.

"XO Score is a new way to prep the vessel," said Jihad Mustapha, M.D., interventional cardiologist, Advanced Cardiac and Vascular Center, Grand Rapids, Mich. "The low-profile design is smooth for tracking to and from the treatment site. But, during balloon inflation, XO Score struts rotate 90 degree on edge to score and cut. Upon deflation, the XO Score rewraps back-to-flat for smooth withdraw."

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 4-8 mm diameter and 20-40 mm long balloons to save the hospital, outpatient lab, ambulatory surgery center (ASC), or office-based lab (OBL) money on each scoring or cutting procedure.

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 degree during balloon inflation to score and cut 0.25 mm (0.010"), 0.35 mm (0.014"), or 0.50 mm (0.020") deep. Struts rotate 90 degree back during deflation.   

"XO Score transforms regular PTA balloons into scoring and cutting systems," said Greg Method, Transit Scientific president. "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. XO Score adds new technology and value to angioplasty."

He said rotating struts allow clinicians to vary scoring depth without increasing device profile. Economically, XO Score offers a direct value proposition: one XO Score plus one off-the-shelf PTA balloon will cost less than one specialty PTA scoring or cutting technology.

This FDA clearance covers the 6.3 Fr (French) XO Score in 65 and 125 cm working lengths with 0.25 mm (0.010"), 0.35 mm (0.014"), or 0.50 mm (0.020") scoring or cutting depths to enable precise dilation across a range of lesion types. Future 3 Fr, 4 Fr, and 5 Fr 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 2 Fr, 2.6 Fr, and 3.8 Fr 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.

For kore information: www.XOScore.com 

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