RadioTherapeutics Introduces RF Ablation System
RadioTherapeutics Corporation announced the marketing launch of its RF Ablation System for the ablation of solid tissue at the first joint meeting of the Society for Surgical Oncology and the World Federation of Surgical Oncology Societies, held March 26 to 29 in San Diego, CA. Additionally, the clinical usefulness of this system in the treatment of liver tumors was the subject of several presentations at the meeting.
The RadioTherapeutics RF Ablation System addresses the significant need for an alternative or complementary treatment for liver tumors that cannot be removed surgically.
The RF Ablation System provides radio frequency energy in a minimally invasive, single-session, cost-effective treatment to heat and destroy (ablate) the solid tumor. The system consists of the RF2000TM Radio frequency Generator and family of LeVeen Needle Electrodes. The proprietary RF2000 generator is an easy-to-operate system capable of creating large, highly uniform and clinically useful lesions over a wide range of tissue types and conditions.
The LeVeen electrodes consist of unique arrays, each made of many evenly spaced wires. Upon deployment, these arrays produce a proprietary umbrella-shaped design that provides consistent, predictable and complete tissue ablation, greatly reducing the chance for tumor or other pathology recurring at the site. Placed through a standard biopsy needle, the LeVeen electrodes may be used either in open surgical or in percutaneous (through the skin) procedures.
In a presentation made Friday, March 27, Walter Gantert, M.D., of the Department of Surgery, University of California San Francisco, reported on the use of the RF Ablation System to treat five patients with malignant liver tumors. Following intraoperative ablation treatment, the liver was resected and assessed to determine the safety and efficacy of the therapy. In all cases homogeneous lesions were achieved. In addition, no thermal damage to surrounding tissue and no intra- or postoperative adverse effects were observed in any of the patients.
A second presentation on the ablation of primary liver tumors was given on Sunday, March 29 by Kenneth Tanabe, M.D., Assistant Professor of Surgery, Massachusetts General Hospital, Boston, MA. Dr. Tanabe discussed the potential of RF ablation technology to treat unresectable liver tumors. He provided an overview of worldwide clinical results with several ablative techniques, and concluded that RF ablation, a relatively new medical technology for unresectable tissue, appears promising in comparison to other ablative techniques. However, longer-term follow up is necessary and may confirm the efficacy of RF ablation.
The LeVeen Needle Electrodes received marketing clearance from the U.S. Food and Drug Administration (FDA) in 1998 for the thermal ablation of soft tissue. The RF2000 generator was cleared for use with the LeVeen electrodes in 1997. Clinical studies are currently being performed using the RF Ablation System for documentation of long-term effectiveness in the treatment of liver and breast tumors at six major cancer centers in the U.S.
RadioTherapeutics Corporation is a privately held medical device company that develops and commercializes minimally invasive therapies that utilize radio frequency Energy.