RITA Medical Systems Inc has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Side-Deployment Electrode, its newest radiofrequency ablation tool designed to safely and precisely ablate small tumors. The Company plans to make the new system available to physicians this month.
The Side-Deployment Electrode is a small gauge needle that allows physicians, using ultrasound imaging guidance, to deliver radiofrequency electrodes directly through the skin and into the tumor in a minimally invasive procedure. This product works much like a hypodermic needle and can ablate a tissue volume of up to 2 centimeters in diameter. It is currently approved in the U.S. to treat liver and bone tumors and approved in Europe to treat lung, kidney, liver, bone and other small tumors.
The Side-Deployment Electrode is the newest addition to RITA's line of electrodes for radiofrequency ablation. The Company now offers electrodes that can ablate tissue volumes ranging from 2 to 7 centimeters in diameter, the widest range currently available on the market.
"This FDA clearance is the latest in a series of regulatory initiatives aimed at strengthening our market position by making the RITA system the most flexible and effective radiofrequency device designed to precisely ablate cancerous and benign tumors," commented RITA's Chief Financial Officer Donald J. Stewart. "The Side-Deployment Electrode offers physicians an effective tool to ablate smaller tumors, which are especially prevalent in cases of lung and kidney cancer."