Hand Held Laser for lymphedema treatmentFDA 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 from the Dr. Vodder School.
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 officially launched the LTU-904 in the USA at the 7th National Lymphedema Network International Conference in Nashville, Tennessee in 2006
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.
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