Expanded use for TheraSphere(R) offers physicians an innovative alternative to traditional liver cancer therapies
10 Gennaio 2007 - 2:00PM
PR Newswire (US)
MDS Nordion receives FDA approval for first Humanitarian Use Device
in the U.S. to treat primary liver cancer patients with portal vein
thrombosis OTTAWA, Jan. 10 /PRNewswire-FirstCall/ -- MDS Nordion, a
leading global provider of medical isotopes and
radiopharmaceuticals used to diagnose and treat disease, announced
today that the U.S. Food and Drug Administration has approved the
use of TheraSphere(R) to treat patients with hepatocellular
carcinoma (HCC), who have partial or branch portal vein thrombosis
(PVT) and have been identified as suitable candidates by their
physicians. HCC is the most common form of primary liver cancer.
Portal vein thrombosis is a blockage, by a blood clot, of the
portal vein, which brings blood to the liver. TheraSphere(R) is the
first medical device approved in the U.S. to treat primary liver
cancer patients with this condition. This expanded use extends the
current approval of TheraSphere(R) as a Humanitarian Use Device for
the treatment of HCC. Treating HCC patients who have PVT using
traditional therapies is often difficult or impossible. Some
treatments can slow or even stop blood flow altogether, potentially
leading to complications for patients with this condition. Unlike
conventional therapies, TheraSphere(R) has been demonstrated to not
significantly alter blood flow to the liver and tumors. With this
treatment, small radioactive glass beads attack cancerous tumors in
the liver, while minimizing the impact on the patient's healthy
tissue. It is injected by a physician into the main artery of the
liver through a catheter which allows the treatment to be delivered
directly to the tumor via blood vessels. According to the American
Cancer Society, approximately 18,500 cases of primary liver cancer
were diagnosed in the United States in 2006. While the rate of
people developing liver cancer has stabilized, the actual number of
liver cancer patients continues to increase with an aging and
growing population. Presently there are limited options available
to treat the disease. "We are excited about providing physicians
with new tools to help in their ongoing fight against cancer," said
Steve West, President of MDS Nordion. "This expanded use for
TheraSphere(R) provides physicians with a new treatment option and
hope for patients with primary liver cancer." Today's announcement
marks a progressive step toward expanding the use of
TheraSphere(R). Last September, MDS Nordion announced that it had
received FDA approval to move forward with clinical trials to test
the effectiveness of TheraSphere(R) in patients with secondary
liver cancer. About TheraSphere TheraSphere(R) is a low toxicity,
out-patient liver cancer therapy which consists of millions of
micro-glass beads containing radioactive yttrium-90. The product is
injected by physicians into the main artery of the patient's liver
through a catheter which allows the treatment to be delivered
directly to the tumor via blood vessels. Unlike chemotherapy, it
has few side effects. Patients rarely experience nausea and
vomiting usually associated with high-dose, systemic
chemotherapies. The TheraSphere(R) treatment can generally be
administered on an outpatient basis and does not usually require an
overnight hospital stay. TheraSphere(R), 100% reimbursed by
Medicare and many commercial health insurers, is approved in the
U.S. as a Humanitarian Device for the treatment of hepatocellular
carcinoma, also referred to as primary liver cancer, and is now
approved for patients who also have partial or branch portal vein
thrombosis and who are identified as suitable candidates by their
physicians. For more information on TheraSphere(R) go to
http://www.therasphere.com/ or visit us at SIR 2007, March 1-6,
2007 in Seattle, Washington, Booth 1215. About MDS Nordion MDS
Nordion (http://www.mds.nordion.com/) is a world leader in medical
isotopes, radiation and related technologies. It is a division of
MDS Inc. (TSX:MDS)(NYSE:MDZ). MDS Inc. is a global life sciences
company that provides market-leading products and services that our
customers need for the development of drugs and diagnosis and
treatment of disease. We are a leading global provider of
pharmaceutical contract research, medical isotopes for molecular
imaging, radiotherapeutics, and analytical instruments. MDS has
more than 8,800 highly skilled people in 28 countries. Find out
more at http://www.mdsinc.com/ or by calling 1-888-MDS-7222, 24
hours a day. DATASOURCE: MDS Nordion CONTACT: Media Inquiries,
Olivia Nixon, MDS Nordion, (613) 592-2790, ext. 2558, (613)
724-1767 (Mobile), ; Investor Inquiries, Sharon Mathers,
Vice-President, Investor Relations and External Communications,
(416) 675-6777, ext. 34721,
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