A Diagnostics & Imaging Week
Ascent Business Solutions (Phoenix), a reprocessor of medical equipment, said it has received FDA 510(k) clearance to reprocess the full line of IBI diagnostic electrophysiology (EP) catheters and cables originally manufactured by Irvine Biomedical (Irvine, California).
These include the Inquiry Fixed and Steerable, AFocus, AFocus II and Optima product families. With this new clearance added to its previously cleared 510(k)s, Ascent said it is the only company that can reprocess diagnostic EP catheters from all major original manufacturers.
Ascent said its focus is on reprocessing "high-cost, high-volume devices such as diagnostic EP catheters to help [our] hospital partners allocate resources to optimize patient care and to help protect the environment through reprocessing, as well as recycling and material reclamation."
It said reprocessing such diagnostic EP catheters saves EP cath labs about 55% over the cost of an original device. The company said a high-volume EP lab using these catheters can expect to save about $175,000 annually.
Irvine Biomedical is a St. Jude Medical (St. Paul, Minnesota) company.