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,

Copyright

Grafico Azioni Mds (NYSE:MDZ)
Storico
Da Giu 2024 a Lug 2024 Clicca qui per i Grafici di Mds
Grafico Azioni Mds (NYSE:MDZ)
Storico
Da Lug 2023 a Lug 2024 Clicca qui per i Grafici di Mds