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April 12, 2022

Transit Scientific’s XO Cross Support Catheter Platform Receives FDA Clearance for Coronary Use

April 12, 2022—Transit Scientific announced FDA 510(k) clearance of the company’s 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.

Transit Scientific will launch the 2-F coronary XO Cross 014 microcatheter for use with standard 0.014-inch guidewires in 90-, 135-, 150-, and 175-cm working lengths. The company stated that the nontapered shaft and tapered polymer tip offer a low crossing profile and facilitate coaxial use through any 0.035-inch compatible coronary guiding catheter.

According to the company, the XO Cross support catheter platform is designed to deliver improved pushability, trackability, flexibility, and torque response for access in challenging lesions and tortuosity. Additionally, the nontapered metal-alloy and polymer construction deliver high fatigue resistance against tough complex lesions found in advanced coronary artery disease, peripheral artery disease, and critical limb ischemia.

“We need better, more controllable, and more durable microcatheters and technology for use in complex coronary lesions and chronic total occlusions,” commented Vasili Lendel, MD, in Transit Scientific’s press release. Dr. Lendel, who is an interventional cardiologist at Arkansas Heart Hospital in Little Rock, Arkansas, continued, “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.”

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