Transit Scientific has announced US Food and Drug Administration (FDA) clearance of its XO Cross support catheter platform to include coronary use. The platform is indicated to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges, and provide a conduit for delivery of saline solutions or diagnostic contrast agents.
Support catheters are used to help navigate guidewires through complex lesions and facilitate guidewire exchanges during interventional procedures in patients with coronary or peripheral artery disease. Legacy technologies often fail to provide sufficient guidewire support, are prone to kinking, and lack the pushability needed to successfully cross severe calcifications and plaque.
The XO Cross support catheter platform is designed to deliver new levels of pushability, trackability, flexibility, and torque response for access in challenging lesions and tortuosity, Transit Scientific said in a press release. The non-tapered metal-alloy and polymer construction delivers high fatigue-resistance against tough complex lesions found in advanced coronary artery disease (CAD), peripheral artery disease (PAD), and critical limb ischemia (CLI).
“We need better more controllable, and more durable microcatheters and technology for use in complex coronary lesions and chronic total occlusions (CTO),” said Vasili Lendel (Arkansas Heart Hospital, Little Rock, USA). “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).”
Transit Scientific will launch the 2Fr coronary XO Cross 014 Microcath for use with standard 0.014″ guidewires in 90cm, 135cm, 150cm, and 175cm working lengths. The non-tapered shaft and tapered polymer tip offer a low crossing profile and facilitate coaxial use through any 035 compatible coronary guiding catheter.
“This new coronary 510k clearance helps us continue to build on the clinical success we’ve had with our XO Cross for peripheral platform,” said Greg Method, president & CEO of Transit Scientific. “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.”