RITA Medical Initiates Feasibility Study of Device for RFA-Assisted Breast Lumpectomy
26 Ottobre 2006 - 1:30PM
PR Newswire (US)
First Three Clinical Cases Using the Investigational Starburst
Assure(TM) RF Electrode Performed FREMONT, Calif., Oct. 26
/PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (NASDAQ:RITA),
a publicly-traded medical device company focused solely on cancer
therapies, today announced that the initial three clinical cases in
the RFA-assisted Lumpectomy feasibility study were performed. The
procedures used the Company's investigational Starburst Assure(TM)
RFA electrode to ablate the wall of the lumpectomy cavity of
patients undergoing breast conserving surgery, immediately
following excision of the primary tumor. The feasibility study is
designed to study the potential of RFA-assisted lumpectomy in
sparing women the necessity and trauma associated with additional
surgery when close or inadequate margins are identified through
pathology examination following lumpectomy procedures. The
procedures were performed by Dr. Antonio Piga and Dr. Carlo Cabula
at the Ospedale Oncologico in Cagliari, Sardinia, Italy. Joseph
DeVivo, President and CEO of RITA commented, "The Assure device is
a novel RFA electrode designed specifically for the breast by our
research and development team and this feasibility trial is the
first step in our efforts to commercialize this new device. The
start of the trial is a very important milestone for RITA and we
are very grateful to Drs. Piga and Cabula and the entire team who
performed these first-ever clinical cases. Our next milestone is to
complete enrollment in this study which we believe we can do on
schedule." The RFA-assisted Lumpectomy feasibility study is
intended as a multi- center study that will include patients from
four centers in Italy. Following surgery, comprehensive
pathological testing is conducted to characterize multiple aspects
of device performance, such as to ensure conclusively the presence
of a tumor-free margin in the lumpectomy cavity. Dr. Jelle W.
Kylstra, Vice President and Medical Director at RITA, commented:
"We are very pleased that three initial procedures with the Assure
device have been performed. We believe that the Assure device
functioned as anticipated during the procedures and we look forward
to completing enrollment and ultimately to evaluating the final
pathology data relating to these and future procedures. With the
start of this trial, we take the development program for
RFA-assisted lumpectomy to an international level." About RITA
Medical Systems, Inc. RITA Medical Systems develops, manufactures
and markets innovative products for cancer patients including
radiofrequency ablation (RFA) systems and embolization products for
treating cancerous tumors as well as percutaneous vascular and
spinal access systems. The Company's oncology product lines include
implantable ports, some of which feature its proprietary Vortex(R)
technology; tunneled central venous catheters; and safety infusion
sets and peripherally inserted central catheters used primarily in
cancer treatment protocols. The radiofrequency product line also
includes the HABIB 4X resection device which coagulates a "surgical
resection plane" and is designed to facilitate a fast dissection in
order to minimize blood loss and blood transfusion during surgery.
The proprietary RITA RFA system uses radiofrequency energy to heat
tissue to a high enough temperature to ablate it or cause cell
death. In March 2000, RITA became the first RFA 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
also distributes LC Bead embolic microspheres in the United States.
The LC Bead microspheres are injected into selected vessels to
block the blood flow feeding a tumor, causing it to shrink over
time, and are often used in combination with RFA. The RITA Medical
Systems website is at http://www.ritamedical.com/ . The statements
in this news release related to the potential outcomes for breast
cancer patients treated with RFA-assisted lumpectomies and the
continuation of the RFA assisted lumpectomy feasibility study are
forward- looking statements involving risks and uncertainties that
could cause actual results to differ materially from those in such
forward-looking statements. Such risks and uncertainties include
but are not limited to: the Company's ability to compete with
companies offering alternative therapies for solid cancerous and
benign tumors; the Company's lack of data regarding the safety and
efficacy of the investigational Starburst Assure radiofrequency
electrode; and delay of product introductions or modifications as a
result of the FDA regulatory process. Information regarding these
risks and other risks and uncertainties is included in the
Company's filings with the Securities and Exchange Commission.
DATASOURCE: RITA Medical Systems, Inc. CONTACT: investors, Doug
Sherk, , or Jenifer Kirtland, both of EVC Group, +1-415-896-6820,
for RITA Medical Systems, Inc.; or Stephen Pedroff, VP Marketing
Communications of RITA Medical Systems, Inc., +1-510-771-0400, or ;
or media, Steve DiMattia of EVC Group, +1-646-277-8706, or , RITA
Medical Systems, Inc. Web site: http://www.ritamedical.com/
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