FDAnews Device Daily Bulletin


May 10, 2006

The FDA has given marketing clearance to Boulder, Colo.-based Valleylab for the company's Cool-tip RF ablation system. The system is the only device cleared for marketing to physicians for use in ablating non-resectable liver tumors. It is a minimally invasive alternative for patients with hepatic cancer who are not ideal surgical candidates or are otherwise unable to be successfully treated with other methods.

"The FDA clearance for radiofrequency ablation of liver tumors and not just 'tissue/liver lesions' allows for ablation of unresectable liver tumors of various histologies," said Robert Martin, a professor in the Division of Surgical Oncology at the University of Louisville School of Medicine. "It is important to help educate physicians skeptical of this technique in regard to radiofrequency ablation efficacy and safety."

The Cool- tip RF system works by combining a radiofrequency generator with a 17-gauge internally cooled needle electrode to deliver therapeutic energy directly to the tumor. The electrode is inserted through the tissue and is guided to the tumor using imaging technology such as CT or ultrasound. Radio waves create energy at the needle tip to heat and destroy the tumor from the inside out. During the ablation, water internally circulates through the electrode cooling adjacent tissue. This maximizes the amount of energy that can be delivered and creates the largest ablation possible in a minimal amount of time. Because ablation with the system is minimally invasive, the procedure can be repeated until the entire liver tumor is ablated.