| NEWS RELEASE: NOVEMBER 2006
FDA Clears Laser-Based Lymphedema Therapy The Food and Drug Administration (FDA) has cleared the RianCorp LTU-904 low-level laser device as an additional weapon in the battle for better quality of life for people living with lymphedema. After a four-year evaluation, the FDA cleared the LTU-904 for use as part of a therapy regime to treat post-mastectomy lymphedema. FDA clearance permits therapists throughout the USA to use the hand-held battery-powered device to treat a patient with lymphedema. Lymphedema, which affects as many as 30% of post-mastectomy patients, is a chronic condition that impacts about three million people in the US. It causes a person’s limb to enlarge because lymphatic fluid does not drain from the limb after the lymphatic system is compromised following breast surgery. Since 2000, therapists in Australia have used the LTU-904 to treat patients with lymphedema. The FDA noted that the RianCorp LTU-904 laser therapy unit has been evaluated in a placebo-controlled double blind clinical trial of post-mastectomy lymphedema patients in Australia. Conducted under ethics committee approval by Flinders University, the study is the world’s only randomized double blind study of a physical treatment for post-mastectomy lymphedema. The Flinders research team is internationally recognized in the area of lymphology and lymphedema treatment. More than half the patients receiving LTU-904-based therapy experienced a reduction in ECF The trial showed that 52% of patients experienced a clinically significant decrease in Extra Cellular Fluid (ECF) after six weeks of laser treatment. In contrast, only 19% of placebo patients experienced the same result. The trial’s results were published in the highly-regarded peer-reviewed journal “Cancer”. The Flinders study enrolled 64 post-mastectomy patients with at least 200 ml difference between their arms. A summary of the clinical trial results is available at http://www.riancorp.com/. The LTU-904 Laser Therapy Unit is a non-thermal device that delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam. The near-infrared beam is invisible to the human eye. The FDA noted that investigators observed no adverse effects from the laser treatments and the study demonstrated the LTU-904 functioned as intended in all treatments of post-mastectomy lymphedema. RianCorp is officially launching the LTU-904 in the USA at the 7th National Lymphedema Network International Conference, running in Nashville, Tennessee, from November 1-5. Director of the Lymphoedema Assessment Clinic at Flinders University, Professor Neil Piller, who supervised the study, said the LTU-904 provided therapists with a powerful tool for reducing the impact of lymphedema on the lives of their patients. “The LTU-904 laser is a very significant, clinically-proven treatment option for lymphedema patients, the first new one in many years,” he said. “Current lymphedema treatments can be time-consuming, are continuous and often very expensive: They typically require patients to develop rigorous maintenance programs that are life-changing. “The LTU-904 significantly benefits from 20-30% of treated lymphedema patients in a treatment that takes less time, requires fewer consultations and has a lower overall cost. It provides therapists with a valuable new treatment option for patients with lymphedema.” RianCorp is a privately-owned company established since 1998. The company has sold the LTU-904 in Australia, Japan, the UK and other countries. More information is available at www.riancorp.com. RianCorp Pty Ltd: Email: sales@riancorp.com 2/331 Seaview Road, Henley Beach, South Australia 5022 Telephone (country code 61) 8 8232 8822: Fax (country code 61) 8 8232 8833 |
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| Canada's London Regional Cancer Centre is investigating a homeopathic cream and oral preparation that has been touted as a treatment for lymphedema called Lymphdiaral.
The Lymphdiaral Study and involves a 12 week trial of a homeopathic cream and oral drops taken by mouth in water. The study subjects will be randomized to one of two treatment arms. Arm 1 receives the standard therapy of a compression sleeve and Arm 2 receives standard therapy plus the Lymphdiaral preparations. Cost of the Lymphdiaral is covered - the sleeves are funded as usual practice by the ADP program. To be eligible you must have been diagnosed with breast cancer and have completed all treatments. In order to measure effect, patients must have at least 200 ml of fluid excess in the affected arm. This is assessed at the first visit. Patients with metastatic disease are not eligible. If a patient has been previously treated for lymphedema they are also not eligible. The study involves 12 weeks of active treatment and 12 weeks of observation. In the first 12 weeks patients attend the cancer clinic every two weeks for 4 visits and then every 4 weeks for 2 visits; a final visit occurs at week 24. At each visit measurements and quality of life questionnaires are done. It is expected that all patients will be fitted for a compression garment at the beginning of the study prior to randomization and will wear the sleeve on a daily basis for the 24 weeks of the study. For information on how you can participate in this study contact: Lyn Kligman, RN, MN, ACNP Nurse Practitioner, Breast Disease Site Team Supportive Care, London Regional Cancer Program 790 Commissioners Rd. East, London, ON N6A 4L6 Canada E-mail: lyn.kligman@lhsc.on.ca |
| LYMPHLAND |
