FDA Gives Marketing Clearance for the Cool-tip™ RF Ablation System for Use with Non-Resectable Liver Lesions

Valleylab’s Cool-tip™ System Intended to Treat Patients Where Surgery is Not an Option

CHICAGO, Ill., November 28, 2004, RSNA Booth #6505 – Valleylab, a business unit of Tyco Healthcare Group LP, today announced that the Food and Drug Administration has issued marketing clearance for the 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 non-resectable liver lesions. Using radiofrequency current, the Cool-tip™ RF ablation system allows physicians to treat patients who are not ideal surgical candidates or are otherwise unable to be successfully treated with other methods.

“FDA concurrence with the Cool-tip™ system for use with non-resectable liver lesions represents a significant advancement for Valleylab,” said Scott Drake, president of Valleylab. “Now we are able to offer an excellent option to patients with these lesions who are not able to be treated through alternative methods.”

The Cool-tip™ RF system utilizes a unique combination of radiofrequency current and internal electrode cooling to effectively heat and coagulate large volumes of tissue. During the ablation process, the 17-gauge electrode internally circulates water to cool the tissue adjacent to the exposed electrode, maximizing energy deposition and minimizing tissue charring. In addition, the system’s generator software monitors tissue impedance and adjusts the output accordingly.

Valleylab, a business unit of Tyco Healthcare Group LP, is the leader in the innovation and manufacture of advanced energy-based medical systems, including a complete line of electrosurgical generators, accessories, and disposable products, a vessel sealing system, patient return electrodes, argon-enhanced electrosurgery systems, laparoscopic instruments, radiofrequency treatment systems, and smoke evacuation devices.

Tyco Healthcare is a leading manufacturer, distributor, and servicer of medical devices worldwide. Its broad portfolio includes disposable medical supplies, monitoring equipment, medical instruments, and bulk analgesic pharmaceuticals, sold under such names as Auto Suture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, Sherwood, United States Surgical, Syneture, Valleylab, and others.