RITA Medical Systems Announces FDA 510(k) Clearance of HABIB 4X Laparoscopic(TM) Device
17 Ottobre 2006 - 1:30PM
PR Newswire (US)
Company Expects to Begin Shipping Product in the Second Half of the
Fourth Quarter of 2006 FREMONT, Calif., Oct. 17
/PRNewswire-FirstCall/ -- RITA Medical Systems, Inc. (NASDAQ:RITA),
a publicly-traded medical device company focused solely on cancer
therapies, today announced that the HABIB 4X Laparoscopic(TM)
resection device received 510(k) marketing clearance from the U.S.
Food and Drug Administration (FDA). Anticipated commencement of
sale of the new product continues to be ahead of schedule, as
reported in the Company's second quarter 2006 earnings conference
call. The Company expects to make first domestic shipments of the
product to its customers in the second half of the fourth quarter
of 2006. The Company expects to complete CE mark certification so
that sales of the product in Europe may begin at the same time
product begins shipping in the U.S. Joseph DeVivo, President and
CEO of RITA Medical, commented, "The laparoscopic version of the
Habib 4X device was developed in direct response to demands from
our surgeon customers who are dedicated to providing the benefits
of minimally invasive surgical techniques to their patients. We are
particularly proud of the fact that the device was developed
entirely in-house, and that we will manufacture the device at our
Manchester, Georgia facility." Mr. DeVivo continued, "Introduction
of the laparoscopic Habib represents another critical milestone in
the execution of our long-term strategy to offer our customers
valuable and novel technology to treat a wide range of patients
with cancer. We expect that the laparoscopic product launch will
occur during the fourth quarter and will continue the positive
momentum the Habib 4X has developed in the marketplace." The Habib
4X Laparoscopic resection device coagulates a surgical resection
plane to facilitate a fast dissection with limited blood loss. The
Company believes this technology will be utilized in a variety of
cancer surgeries, including liver and kidney, as it is designed to
minimize blood loss and blood transfusion during resection.
Additionally the Habib 4X Laparoscopic resection device is designed
to work on the current RITA RFA platform of 1500X(TM) Generators.
The HABIB 4X Laparoscopic resection device is intended to be used
to assist in coagulation of tissue during intraoperative and
laparoscopic surgical procedures. The Company has been selling the
Habib 4X(TM) Resection Device since the third quarter of 2005. The
new HABIB 4X Laparoscopic resection device incorporates technology
licensed by RITA Medical Systems, Inc. from United Kingdom based
EMcision Limited. "Habib" is a licensed trademark of EMcision
Limited. 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 radiofrequency
ablation (RFA). The RITA Medical Systems website is at
http://www.ritamedical.com/. The statements in this news release
related to the introduction of the HABIB 4X Laparoscopic resection
device in the second half of the fourth quarter of 2006; that the
laparoscopic version of the HABIB 4X resection device will continue
the positive momentum the product has developed in the marketplace;
the performance of the HABIB 4X Laparoscopic resection device; and
physician adoption of the HABIB 4X Laparoscopic Resection device
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 risk of product defects,
recalls or failures; potential product delays caused by unforeseen
manufacturing challenges; reliance on a small number of suppliers
for components of the HABIB 4X Laparoscopic resection device;
compliance with FDA regulations; and physician training efforts.
Information regarding these risks is included in the Company's
filings with the Securities and Exchange Commission. DATASOURCE:
RITA Medical Systems, Inc. CONTACT: Stephen Pedroff, VP Marketing
Communications of RITA Medical Systems, Inc., +1-510-771-0400, or ;
or investors, Doug Sherk, , or Jenifer Kirtland, , both at
+1-415-896-6820, or media, Steve DiMattia, +1-646-277-8706, or ,
all of EVC Group, for RITA Medical Systems, Inc. Web site:
http://www.ritamedical.com/
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