FDA Clears XableCath Crossing Catheters
January 30, 2019—XableCath, Inc. announced that its XableCath blunt and abrasion tip catheters were cleared by the FDA as peripheral crossing catheters. XableCath is commencing a selective commercial launch in Q1 2019.
The catheters have been safely and successfully used to cross challenging lesions in both arterial chronic total occlusions and chronic obstructive venous lesions. The crossing clearance adds to the previous clearances for endovascular support.
According to the company, the device's catheter tip design and true lumen, over-the-wire technology provide intuitive, easy-to-use, effective, and safe crossing of arterial and venous lesions. Additionally, the XableCath's flexibility and strong columnar support and its abrasion tip configuration are suited for treating challenging, recalcitrant chronic venous occlusions, stated the company.