FDA Clears RF Ablation System for Use in Nonresectable Liver Tumors

Valleylab recently announced that the US Food and Drug Administration (FDA) approved marketing of the Cool-tip radiofrequency (RF) ablation system. The Cool-tip RF ablation system is the first and only device cleared for marketing to physicians for use in ablating nonresectable liver tumors. This 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, solidifies the company's commitment to the oncology market.

"The recent 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, MD, assistant professor, 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."

"Interventional oncologists have been ablating liver tumors since the mid-90s with the Cool-tip RF ablation system," said Damian Dupuy, MD, professor of diagnostic imaging at Brown Medical School and director of tumor ablation at Rhode Island Hospital. "The continued acceptance of this procedure is a testament to the technology and the hard work that interventional oncologists have done over the last decade."

How It Works

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 computed tomography or ultrasound. Radiowaves 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 Cool-tip ablation system is minimally invasive, the procedure can be repeated until the entire liver tumor is ablated.