Monday April 24
SOURCE: RITA Medical Systems, Inc.
Clearance for Unresectable Liver Patients
Calif., April 24 /PRNewswire/ -- RITA Medical Systems, Inc. announced
today that it received clearance on March 27, 2000 from the U.S. Food and
Drug Administration (FDA) to market its radiofrequency (RF) products for
the ablation of non-resectable liver lesions. The company noted that
non-resectable lesions represent the majority of all liver lesions,
according to the clinical literature. RITA believes it is the first RF
company to receive a liver-specific clearance in the United States. In
March, RITA launched its newest product, the RITA Model 1500 Generator and
Starburst line of needle electrode accessories, at the Society of Surgical
Oncology Annual Meeting in New Orleans, LA. This system includes the first
deployable electrode designed to create ablations up to 5 cm in diameter
using real time tissue temperature feedback.
RITA also announced
that a scientific study was recently published in the Annals of Surgical
Oncology entitled ``Local Recurrence After Laparascopic Radiofrequency
Thermal Ablation of Hepatic Tumors,'' by Allan Siperstein, MD, et. al. Dr.
Siperstein, a surgeon at the Cleveland Clinic, concludes in his article
that ablation using RITA's system ``seems to be a safe and effective
treatment technique for patients with primary and metastatic liver
malignancies.'' The study involved the use of the RITA system on 181 liver
lesions in patients who were not candidates for surgical resection.
RITA Medical Systems,
Inc. is a privately held medical device company which develops, markets
and sells products used to destroy benign and cancerous tumors. The
company's products are marketed throughout the world including the United
States, Europe and Asia. In the United States, RITA's products are cleared
for the ablation of soft tissue, including unresectable liver lesions.