www.fdanews.com/articles/207561-fda-clears-four-coronary-micro-support-catheters-from-transit-scientific
FDA Clears Four Coronary Micro Support Catheters from Transit Scientific
April 27, 2022
Park City, Utah-based Transit Scientific has received the FDA’s 510 clearance for its XO Cross support catheters to include coronary use and four individual micro-catheters.
Support catheters are used to help navigate guidewires and facilitate guidewire exchanges during surgical procedures in patients with coronary or peripheral artery disease.
The XO Cross platform also provides a conduit for delivery of saline solutions or diagnostic contrast agents.
The support catheters are made of metal-alloy and polymer materials that enable them to push through complex lesions, including calcium and plaque found in advanced coronary artery disease, peripheral artery disease and critical limb ischemia.