Transit Scientific today announced it received FDA 510(k) clearance for its XO Cross support catheter platform for coronary use.
Park City, Utah-based Transit Scientific designed the support catheter to deliver pushability, traceability and torque response for improved access in challenging peripheral lesions. It has a non-tapered, metal-alloy and polymer construction that delivers high fatigue-resistance for tough calcium and plaque in late-stage peripheral artery disease and critical limb ischemia patients.
The support catheters are indicated by the FDA to guide and support a guidewire during peripheral or coronary vasculature access, allow for wire exchanges and provide a conduit for saline and diagnostic contrast agents.
“We need better more controllable, and more durable microcatheters and technology for use in complex coronary lesions and chronic total occlusions (CTO),” said Dr. Vasili Lendel, an interventional cardiologist at Arkansas Heart Hospital in Little Rock, Arkansas. “The trackability and high-torque response of the XO Cross platform will help us gain wire access in challenging coronary tortuosity and worst-case calcium and plaque. We’ve seen great results with XO Cross in our peripheral vascular procedures, so we look forward to using this platform for Percutaneous Coronary Interventions (PCI).”
With the FDA clearance, Transit Scientific plans to launch its 2 FR coronary XO Cross 014 microcatheter for use with a standard 0.014 in. guidewires in 90 cm, 135 cm, 150 cm and 175 cm lengths.
“This new coronary 510k clearance helps us continue to build on the clinical success we’ve had with our XO Cross for peripheral platform,” CEO Greg Method said. “This is an important milestone for our team as it further expands our mission of delivering novel and effective technologies for the treatment of arterial and venous disease.”