Technology | Chronic Total Occlusion (CTO) | January 30, 2019

FDA Clears XableCath Crossing Catheters

New tool for crossing peripheral chronic total occlusions and chronic venous obstructions

FDA Clears XableCath Crossing Catheters

January 30, 2019 — XableCath Inc., announced that its XableCath blunt and abrasion tip catheters were cleared by the U.S. Food and Drug Administration (FDA) as peripheral crossing catheters. The catheters have been safely and successfully used to cross challenging lesions in both arterial chronic total occlusions (CTOs) and chronic obstructive venous lesions. The recent crossing FDA clearance adds to the previous clearances for endovascular support.

Data collected in 11 medical centers in the U.S. and the E.U. have demonstrated a 95 percent success rate in crossing arterial lesions with the devices, and 100 percent success in crossing venous lesions. In more than 70 cases, zero complications have been observed related to XableCath usage.

The company is commencing a selective commercial launch this quarter and will be developing a coronary version of its Crossing Catheter.

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