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FDA Clears Valleylab's Cool-Tip RF Ablation System for Use in Ablating Non-Resectable Liver Tumors





Valleylab regarded as the only radiofrequency ablation company cleared to market device to phyicians





BOULDER, Colo. May 8, 2006 — Valleylab today announced the United States Food and Drug Administration’s (FDA) marketing clearance issuance for the Cool-tip™ RF ablation system. The Cool-tip™ RF ablation system is the first and only device cleared for marketing to physicians for use in ablating non-resectable 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-90’s 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.�

Awareness and use of radiofrequency ablation is increasing, as made evident by the growth in Cool-tipâ„¢ RF ablation system sales. The Cool-tipâ„¢ RF ablation 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 Cool-tipâ„¢ ablation system is minimally-invasive, the procedure can be repeated until the entire liver tumor is ablated.

“We are proud to be the first radiofrequency ablation company to receive FDA clearance for the ablation of non-resectable liver tumors,� said Kevin Seifert, president of Valleylab. “It is very important for us as a company to be able to provide physicians with a comprehensive offering of safe and effective Valleylab products for their patients with inoperable liver tumors.�

About Valleylab

Valleylab, a division of Tyco Healthcare Group LP, is the world leader in the innovation and manufacture of advanced energy-based medical systems, including a complete line of electrosurgical generators, accessories, and disposable products, the LigaSureâ„¢ vessel sealing system, patient return electrodes, argon-enhanced electrosurgery systems, laparoscopic instruments, radiofrequency treatment systems, and smoke evacuation devices. More information can be found at www.valleylab.com.

About Tyco Healthcare

As a major business segment of Tyco International Ltd., (NYSE:TYC), Tyco Healthcare manufactures, distributes and services an extensive product line including disposable medical supplies, monitoring equipment, innovative wound closure products, advanced surgical devices, medical instruments and bulk analgesic pharmaceuticals. With industry-leading brand names such as Autosuture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, Syneture, and Valleylab, Tyco Healthcare products are found in virtually every healthcare setting. More information can be found at www.tycohealthcare.com.