Celsion Corporation of Columbia, Md., has announced it will resume shipments of its Prolieve Thermodilatation system for benign prostatic hyperplasia (BPH) after clearance from the FDA’s Center for Devices and Radiological Health.


Changes in the manufacturing and inspection process for components in Prolieve’s disposable catheter kit were approved by the agency after a recall had taken it off the market for about four months.

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Lawrence Olanoff, MD, Celsion’s chief executive officer, said the company is arranging to start shipments of the finished catheter kits to its distributor, Boston Scientific.