VIVA combo RF System

The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. The VIVA combo RF generator, STAR RF Electrodes, and VIVA RF Electrodes are indicated for ultrasound-guided percutaneous ablation of cytologically-confirmed benign thyroid nodules in adults. Benign thyroid nodules (BTNs) may require treatment if they are symptomatic or autonomously functioning. Minimally invasive ultrasound-guided radiofrequency ablation (RFA) has been employed as an alternative to surgery for BTNs requiring treatment.

The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. The VIVA combo RF generator, star RF Electrodes, and VIVA RF Electrodes are indicated for ultrasound-guided percutaneous ablation of cytologically-confirmed benign thyroid nodules in adults that are symptomatic, cosmetically concerning, and/or autonomously functioning. Autonomously functioning nodules are indicated if nodule volume is < 10 mL.

The VIVA combo RF System consists of an RF generator, active electrodes, a grounding pad and a peristaltic pump for electrode cooling. The VIVA combo RF generator is designed to produce local tissue heating at the tip of the electrodes, causing the coagulation and ablation of tissue. The VIVA combo RF generator is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors power, resistance, current, and temperature. The VIVA combo RF generator also includes software that continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjusts RF output accordingly. The star RF Electrodes and VIVA RF Electrodes are sterile, single-use electrosurgical accessories intended to be used in conjunction with the VIVA combo RF generator. They are not intended to function with other RF generators. Cooling of the electrode is provided by chilled water, which is pumped through the inflow tubing, through the electrode, and out through the outflow tubing. The system is enclosed within the electrode; the water for cooling is not in contact with the patient. All electrodes use stainless steel 304 for the electrode tip. The main differences between the various star RF Electrodes and VIVA RF Electrodes are: (a) handle design, (2) insulating material, and (3) size (i.e., electrode length, tip length, and/or diameter (gauge)). VIVA RF Electrodes have an adjustable tip length and are available in three subtypes: VIVA RF Electrode, VIVA RF Electrode V2 type and VIVA RF Electrode V2-T. The differences among electrodes do not impact product performance and safety. For the benign thyroid nodule indication, the clinically supported electrode configuration consists of the VIVA combo RF Generator used with star RF Electrodes and VIVA RF Electrodes in monopolar mode with continuous radiofrequency power using electrodes with 18–19G diameter, 50–100 mm electrode length, and 4–15 mm exposed tip length at RF power settings of 5–80 W. Electrodes with variable tip exposure lengths greater than 15 mm, including VIVA RF Electrodes, VIVA RF V2 Electrodes, and VIVA RF V2-T Electrodes, should not be extended beyond 15 mm during benign thyroid nodule ablation procedures.