FDA Clears Device for Liver Cancer Treatment

NEW YORK, Apr 12, 2000 (Reuters Health) -- The US Food and Drug Administration (FDA) has given marketing approval for a device used in treating inoperable cancers of the liver, according to the device manufacturer, Sunnyvale, California-based RadioTherapeutics.

The RF Ablation System uses radiofrequency energy to "heat and destroy" cancerous lesions of the liver. The method can be used as an alternative treatment for lesions that cannot be removed through surgery due to their size, number or location, the company reports.

About 90% of the approximately 2 million cases of liver cancer worldwide fall into this category, RadioTherapeutics said. Tumors may develop in the liver directly or may spread to the organ from other parts of the body.

The system can be used as a "complementary" treatment during open surgery, or laparoscopic (small incision) or percutaneous (through the skin) procedures, the firm said.

During the therapy, a needle electrode is positioned inside the lesion. Radiofrequency energy from a generator is then channeled through the needle to "coagulate and ablate the lesion by heating it to a lethal temperature."

According to the company, a study of 120 patients with inoperable liver tumors found that only 2.4% experienced complications after the procedure. The rate of tumor recurrence was less than 2% in the 15 months after treatment, RadioTherapeutics said.

RadioTherapeutics is exploring the use of the system to treat tumors in other soft tissues, such as breast, lung and kidney. The privately-held firm began marketing the RF system for thermal ablation of soft tissues in early 1998.

Reprinted from: http://dailynews.yahoo.com/h/nm/20000412/hl/dgb_38.html