Lymphoedema
Now Cleared by FDA for Lymphedema Treatment
The American Food and Drug administration has cleared the Riancorp LTU-904 laser therapy units as a tool to be used in the treatment of post mastectomy lymphedema.
The LTU-904 is the ONLY laser device cleared by FDA for lymphedema treatment.
Lymphedema Clinical Trials
Flinders Medical Centre in South Australia has conducted the only randomised double blind trial for any lymphedema treatment in the world. The study has been published in the very reputable journal "Cancer" (2003 edition).
In the trials, 30% of patients had a reduction in limb volume of 200mls or more. This is a significant improvment.
More importantly (for patients) this improvement was maintained for 3 months. The patients had no other treatment, yet continued to improve over the three month follow-up period.
For a better description of the randomised double blind clinical trials please click on the link below to download a hard copy.
Clinical Trial Summary
(40 Kb PDF Document)
FDA Press Release
(76 Kb PDF Document)