Newly Published Prospective Study Establishes Effectiveness of RITA Medical Systems RFA Technology for Treatment of Primary Liver Cancer
"This study showed that patients who receive radiofrequency ablation of their hepatocellular lesions experience survival rates comparable to surgery patients," stated Dr. Alfredo Guglielmi, lead investigator of the study from the First Department of General Surgery, Verona University Medical School, Verona, Italy. "It signals to oncologists, surgeons, and radiologists that RFA is an important treatment option for the overwhelming majority of HCC patients who are not candidates for resection surgery."
Dr. Guglielmi was joined by Dr. Andrea Ruzzenente, Dr. Arrigo Battocchia, Dr. Angelo Tonon, Dr. Girolamo Fracastoro, and Dr. Claudio Cordiano, Chief of the Department, as co-authors of the study.
The study reports that after three years survival was 83 percent in Child-Pugh A cirrhotic patients and 31 percent in Child-Pugh B patients. Fifty-three (53) patients with a total of sixty-five (65) lesions were treated with RFA. All of the patients treated were considered unsuitable for surgical resection due to advanced stage of cirrhosis, tumor multifocality, high surgical risk, or surgical refusal. Only minor complications and no deaths were reported in the first 30 days post-procedure.
"The publication of this study is important information for the 70 percent to 80 percent of newly diagnosed primary liver cancer patients worldwide, for whom curative surgical resection is not an option, and offers further evidence that RFA is a safe and effective treatment for these tumors," stated Mr. Joseph DeVivo, President and CEO of RITA Medical Systems.
"We are very excited about sharing the findings of this important study confirming improvement in survival rates with our customers, their patients, and most importantly with medical professionals who are referring HCC patients for treatment beyond chemotherapy. We believe that the body of scientific evidence is mounting to indicate that patients with liver tumors should be receiving, as a routine compliment to chemotherapy, this highly effective local treatment that completely destroys the tumor, with few complications. This study and others support the notion that these patients, when the clinical indications are correct, will receive the greatest benefit from RFA in terms of survival, if they are referred as early as possible in the disease state," concluded Mr. DeVivo.
About RITA Medical Systems, Inc.
RITA Medical Systems develops, manufactures and markets innovative
products for patients with solid cancerous or benign tumors. The proprietary
RITA system uses radio frequency energy to heat tissue to a high enough
temperature to ablate it or cause cell death. While the Company's current
focus is on liver cancer and metastatic bone cancer, the Company believes that
its minimally invasive technology may in the future be applied to other types
of tumors, including tumors of the lung, breast, uterus, prostate and kidney.
The Company has received regulatory clearance in major markets worldwide,
including the United States. In March 2000, RITA became the first
radiofrequency ablation company to receive specific FDA clearance for
unresectable liver lesions in addition to its previous general FDA clearance
for the ablation of soft tissue. In October 2002, RITA again became the first
company to receive specific FDA clearance, this time, for the palliation of
pain associated with metastatic lesions involving bone. The Company has sold
over 45,000 of its disposable devices throughout the world.
The statements in this news release related to the use of the Company's technology are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.
For further information, please contact: Investors, Jill Bertotti, jill@allencaron.com , or Media, Len Hall, len@allencaron.com , both of Allen & Caron Inc, for RITA Medical Systems, Inc., +1-949-474-4300; or Don Stewart, Chief Financial Officer, dstewart@ritamed.com , or Stephen Pedroff, VP Marketing Communications, spedroff@ritamed.com , both of RITA Medical Systems, Inc., +1-650-314-3400.
SOURCE RITA Medical Systems, Inc.