Healthcare Industry News:  peripheral artery disease 

Devices Interventional Regulatory

 News Release - March 17, 2021

Next-Generation Microcatheter Platform Earns CE Mark Approval

Novel XO Cross catheter platform CE Mark cleared for use in peripheral vasculature.

PARK CITY, Utah, March 17, 2021 -- (Healthcare Sales & Marketing Network) -- Transit Scientific announced it received CE Mark approval in the European Union for its non-tapered metal alloy XO Cross Microcatheter platform.

Microcatheters are commonly used to provide guidewire support, facilitate guidewire exchanges, access distal anatomy, cross lesions, deliver therapeutic embolics, and inject contrast media, during complex endovascular procedures.

"XO Cross incorporates a unique non-tapered design that gives it guidewire-like 1:1 torque response," said George Adams, MD Interventional Cardiologist, UNC REX Healthcare, Raleigh, NC. "The low-profile 2F XO Cross enabled easy access and wire support for a pedal retrograde approach through a 2.9F micro puncture sheath rather than needing a larger 4F introducer."

The XO Cross platform is designed to deliver new levels of pushability, trackability, and torque response for improved access in challenging peripheral lesions. The non-tapered, metal-alloy and polymer construction delivers high fatigue-resistance for tackling tough calcium and plaque found in late-stage peripheral artery disease (PAD) and critical limb ischemia (CLI) patients.

"We encounter increasingly complex, difficult lesions that require new sophisticated microcath technologies and approaches," said Eric Dippel, MD Interventional Cardiologist Vascular Institute of the Midwest, Davenport, IA. "XO Cross helps fill that need by enabling better control, response, and tip shapeability for improved wire support and crossing."

Having completed a successful multi-site multi-user limited release in the United States, Transit Scientific will launch the 2Fr XO Cross 14 Microcath, 2.6Fr XO Cross 18 Microcath, and the 3.8Fr XO Cross 35 Support Catheter in Europe over the coming months. XO Cross is a comprehensive support catheter platform available in 90cm, 135cm, 150cm, and 175cm working lengths for use with standard 0.014", 0.018", and 0.035" guidewires. The longer 175cm versions are designed to support radial artery to peripheral access or pedal access from a contralateral femoral approach.

"This CE Mark clearance expands our ability to deliver new technologies designed to improve patient care in the European market," said Greg Method President of Transit Scientific in Park City, Utah. "We've been thrilled with the results we achieved thus far with our early US users and believe XO Cross represents the future of micro and support catheter design. CE Mark approval was an important milestone that paves the way for future versions and applications of this unique technology."

Transit Scientific is a private company that designs, develops, and commercializes medical devices including the CE Mark and FDA cleared XO Cross microcatheters and FDA cleared XO Score scoring sheath.

Source: Transit Scientific

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