FDA Clears Laser-Based Lymphedema Therapy

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FDA Clears Laser-Based Lymphedema Therapy

Oct/Nov 2006

News Release

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 handheld 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 randomised double blind study of a physical treatment for post-mastectomy lymphedema. The Flinders
research team is internationally recognised in the area of lymphology and
lymphedema treatment.

More half of patients receiving LTU-904-based therapy experienced a reduction in ECF The trial showed that 52% of patients experienced a clinically significant decrease in ECF (Extra Cellular Fluid) after six weeks of laser treatment. In contract 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 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

7 Fleet St Richmond
South Australia 5022

Telephone (country code 61) 8 8232 8822: Fax (country code 61) 8 8232 8833

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Lymphedema People

http://www.lymphedemapeople.com

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Lymphedema Clinical Trials Low Level Laser

Flinders Medical Centre in South Australia has conducted the only randdomised double blind trial for any lymphedema treatment in the world. The study has been published in the very reputable journal "Cancer".

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 see Cancer, 2003 Volume 98, Issue 6, Pages 1114-1122. (Abstract below)

Treatment of postmastectomy lymphedema with low-level laser therapy

A double blind, placebo-controlled trial
Colin J. Carati, Ph.D. 1 *, Sandy N. Anderson, B.Sc. 2, Bren J. Gannon, Ph.D. 1, Neil B. Piller, Ph.D. 2
1Department of Anatomy, School of Medicine, Flinders University, Adelaide, South Australia, Australia
2Lymphoedema Assessment Clinic, Surgical Oncology Unit, Flinders Medical Centre and Department of Surgery, Flinders University, Adelaide, South Australia, Australia
email: Colin J. Carati (colin.carati@flinders.edu.au)
*Correspondence to Colin J. Carati, Department of Anatomy, School of
Medicine, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001 Australia Fax: (011) 61 8 82045935

Dr. Carati occasionally acts as a consultant for Rian Corporation, the
manufacturer of the laser used in this study. Rian Corporation had no input to the analysis of the study or the preparation of the article.
Funded by: Australian Government AUSIndustry grant to RIAN Corporation and Flinders University

2003

Keywords
lymphedema • low-level laser therapy (LLLT) • breast neoplasms • treatment

Abstract

BACKGROUND
The current study describes the results of a double blind,
placebo-controlled, randomized, single crossover trial of the treatment of patients with postmastectomy lymphedema (PML) with low-level laser therapy (LLLT).

METHODS
Participants received placebo or one cycle or two cycles of LLLT to the
axillary region of their affected arm. They were monitored for reductions in affected limb volume, upper body extracellular tissue fluid distribution, dermal tonometry, and range of limb movement.

RESULTS
There was no significant improvement reported immediately after any of the treatments. However, the mean affected limb volume was found to be significantly reduced at 1 month or 3 months of follow-up after 2 cycles of active laser treatment. Approximately 31% of subjects had a clinically significant reduction in the volume of their PML-affected arm (> 200 mLs) approximately 2-3 months after 2 cycles of treatment. There was no significant effect of placebo treatment, or one cycle of laser treatment, on affected limb volume. The extracellular fluid index of the affected and unaffected arms and torso were reported to be significantly reduced at 3 months after 2 cycles of laser therapy, and there was significant softening of the tissues in the affected upper arm. Treatment did not appear to improve range of movement of the affected arm.

CONCLUSIONS
Two cycles of laser treatment were found to be effective in reducing the
volume of the affected arm, extracellular fluid, and tissue hardness in
approximately 33% of patients with postmastectomy lymphedema at 3 months after treatment. Cancer 2003;98:1114-22. © 2003 American Cancer Society.

http://www3.interscience.wiley.com/cgi- ... 1&SRETRY=0

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Low-level laser therapy in management of postmastectomy lymphedema

2006

Kaviani A, Fateh M, Yousefi Nooraie R, Alinagi-zadeh MR, Ataie-Fashtami L.
Tehran University of Medical Sciences and Iranian Center for Medical Laser Research, Tehran, Iran. akaviani@sina.tims.ac.ir

Keywords: LLLT - Postmastectomy lymphedema - Breast cancer

The aim of this paper was to study the effects of low-level laser therapy (LLLT) in the treatment of postmastectomy lymphedema. Eleven women with unilateral postmastectomy lymphedema were enrolled in a double-blind controlled trial. Patients were randomly assigned to laser and sham groups and received laser or placebo irradiation (Ga-As laser device with a wavelength of 890 nm and fluence of 1.5 J/cm2) over the arm and axillary areas. Changes in patients' limb circumference, pain score, range of motion, heaviness of the affected limb, and desire to continue the treatment were measured before the treatment and at follow-up sessions (weeks 3, 9, 12, 18, and 22) and were compared to pretreatment values. Results showed that of the 11 enrolled patients, eight completed the treatment sessions. Reduction in limb circumference was detected in both groups, although it was more pronounced in the laser group up to the end of 22nd week. Desire to continue treatment at each session and baseline score in the laser group was greater than in the sham group in all sessions. Pain reduction in the laser group was more than in the sham group except for the weeks 3 and 9. No substantial differences were seen in other two parameters between the two treatment groups. In conclusion, despite our encouraging results, further studies of the effects of LLLT in management of postmastectomy lymphedema should be undertaken to determine the optimal physiological and physical parameters to obtain the most effective clinical response.

http://www.springerlink.com/content/d2216586q54q2351/