Valleylab gets FDA clearance

Valleylab, a business unit of Tyco Healthcare Group, said that the U.S. Food and Drug Administration has issued marketing clearance for its Cool-tip RF ablation system for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of nonresectable liver lesions.

Cool-tip RF uses a combination of radiofrequency current and internal electrode cooling to heat and coagulate large volumes of tissue to treat patients who are not ideal surgical candidates or are otherwise unable to be successfully treated with other methods, according to the Boulder, CO-based firm.

The company has also introduced a new switching controller for Cool-tip RF. The new technology enables physicians to use up to three electrodes simultaneously, allowing them to ablate larger volumes of tissue or create multiple separate lesions in one ablation cycle, Valleylab said.

By staff writers
January 5, 2005

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