SUNNYVALE, CaliforniaRadioTherapeutics Corporation has received
clearance from the FDA to market its RF System for the ablation of
nonresectable liver lesions. The system, consisting of the RF 2000
Radio-frequency Generator and family of LeVeen Needle Electrodes,
provides radiofrequency (RF) energy to heat and destroy soft tissue.
In one multicenter clinical study of the RF System, more than 120
patients with unresectable liver tumors received RF ablation.
Post-procedure complications were limited to 2.4% of patients, and
the rate of tumor recurrence was less than 2% with a median follow-up
of 15 months, the company said in a news release.
To perform the RF procedure, the physician uses ultrasound or CT
imaging to guide a small LeVeen Needle Electrode directly into the
target liver lesion. Once positioned inside the lesion, an array of
wire tines in the shape of an umbrella (see Figure) penetrates a
larger volume about the needle. Radiofrequency energy, provided by
the RF 2000 generator, is then applied to coagulate and ablate the
lesion by heating it to a lethal temperature.