Low Level Laser FDA Cleared for the Treatment of Lymphedema

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BioHorizon Medical Inc., a nationwide distributor of products used to treat lymphatic and venous disorders, will be distributing the first Low Level Laser for the treatment of lymphedema. This device is manufactured by Rian Corp and was cleared by the FDA in November 2006.

BioHorizon Medical, Inc. Appointed first Distributor in USA.

Following FDA approval, Riancorp has announced that Biohorizon Medical in California will be the first US based distributor for the LTU-904 laser therapy unit.

After a four-year evaluation, the FDA has authorised the LTU-904 for use as part of a therapy regime to treat post-mastectomy lymphedema. FDA clearance permits therapists throughout the US to use the hand-held battery-powered device when they treat a patient with lymphedema.

Biohorizon Medical is a leader in providing lymphedema treatment options to patients and therapists in the USA. Mark Knight, President of Biohorizon said "we are very pleased to be working with Riancorp" "it is wonderful to see a new device for lymphedema that has sound clinical data to back up the product".

The FDA identified 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.

The study, conducted under ethics committee approval by Flinders University at Flinders Medical Centre, is the world's only randomised double blind study on a physical treatment for post-mastectomy lymphedema. The Flinders research team is internationally recognised in the area of lymphology and lymphedema treatment.

The trial's results were published in a peer-reviewed journal.

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 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 US at the 7th National Lymphedema Network International Conference, running in Nashville, Tennessee, from November 1-5.

Flinders University Professor Neil Piller, (Director of the Lymphoedema Assessment Clinic) 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 new treatment option for lymphedema patients. The first in many years," he said. "Current lymphedema treatments can be time-consuming, are continuous and often very expensive: They most often also require patients to develop rigorous maintenance programs that can be demanding and life-changing.

"The LTU-904 significantly benefits more than 30% of treated lymphedema patients, in a treatment that takes less time, requires fewer consultations and has a lower overall cost. This provides a valuable new treatment option for therapists with patients who suffer from lymphedema."

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.

RianCorp is a privatelyowned company established since 1998. The company has sold the LTU-904 in Australia, Japan the UK and other countries.

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