FDA clears Ascent reprocessed EP catheters, cables

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Ascent Healthcare Solutions has received 510(k) clearance from the FDA to reprocess the full line of IBI diagnostic electrophysiology (EP) catheters and cables, originally manufactured by Irvine Biomedical, a St. Jude company.

The catheters and cables include the Inquiry Fixed and Steerable, AFocus, AFocus II and Optima product families that offer a selection and variety of curve designs for varying anatomies, according to the Phoenix-based company.  

Ascent said it focuses on reprocessing high-cost, high-volume devices, such as diagnostic EP catheters, to help its hospital partners allocate resources.