Transit Scientific issued the following announcement on May 12.
Transit Scientific announced the FDA cleared the XO Cross® Microcatheter platform for guidewire support, exchange, and contrast media injection in the peripheral vasculature.
Microcatheters are small 0.70-1.30mm outer diameter (OD) catheters used to provide guidewire support, facilitate guidewire exchanges, access distal anatomy, cross lesions, deliver therapeutic embolics, inject contrast media, and/or perform other procedures during complex endovascular procedures.
"We use multiple microcatheters every day," said George Adams, MD Interventional Cardiologist, UNC REX Healthcare, Raleigh, NC. "Improving access to distal vasculature is important. We are performing more radial procedures too and need long, responsive, and fatigue-resistant microcatheter technology."
The XO Cross Microcatheter platform is designed to deliver new levels of pushability, trackability, flexibility, and torque response to access challenging lesions. The non-tapered metal-alloy and polymer construction delivers high fatigue-resistance against tough calcium and plaque found in late-stage peripheral artery disease (PAD) and critical limb ischemia (CLI).
"Tapered catheter designs with larger proximal shafts make it impossible to use as co-axial or tri-axial systems," said Richard Saxon, MD, FSIR Interventional Radiologist, Tri-City Medical Center. "The XO Cross non-tapered design should dramatically reduce that problem and help us achieve success more quickly, even in the most difficult cases."
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 for use with standard 0.014", 0.018", and 0.035" guidewires in 90cm, 135cm, 150cm, and 175cm working lengths. The long 175cm versions are designed to support radial artery access to peripheral cases.
"XO Cross represents next-generation microcath technology," said Greg Method, President of Transit Scientific in Park City, Utah. "The platform delivers new levels of performance against every metric. The unique non-tapered exoskeletal design allows for coaxial dual-support and is intended to expand on, and enable, new techniques for treating complex PAD and CLI cases. This FDA clearance will position Transit to launch its first wave of XO Cross devices in the USA."
Transit Scientific is a private company that designs, develops, and commercializes medical devices including the FDA cleared XO Cross® microcatheters and XO Score® scoring sheath under development. www.XOCross.com
Original source can be found here.
