Betterhealth Naturopathic Clinic

On December 8, the FDA approved a low-level laser therapy unit (LTU-904, made by RianCorp Pty Ltd) for use in the treatment of postmastectomy lymphedema. According to a company news release, lymphedema has a US prevalence of approximately 3 million, affecting as many as 30% of postmastectomy patients. The chronic condition is caused by the effects of breast surgery on the lymphatic system that prevent drainage and result in limb swelling.

The handheld, battery-powered, nonthermal device delivers a controlled series of 200 ns bursts of near-infrared 904 nm laser-beam pulses that yield photochemical reactions at the cellular level, thereby influencing the course of metabolic processes. Designated as a class 1 laser, the unit is eye-safe for patients and clinicians.

According to company information, advantages associated with the laser's use include painless and often immediate analgesic effects at the time of treatment and a shortened recovery time with rapid reduction of inflammation.

The approval was based in part on data from a placebo-controlled, double-blind clinical trial of 64 patients in Australia who received active treatment or placebo three times weekly for two 3-week blocks.

Results at 6 weeks showed that 52% of laser-treated patients experienced clinically significant decreases in extracellular fluid levels compared with 19% of those receiving placebo; the number of patients achieving a 200 mL or greater decrease in limb volume was also higher (31% vs placebo, 4%). Improvements continued to progress during a 3-month follow-up period with no further treatment.

The laser therapy unit was previously approved in Australia, where it has been marketed for this indication since 2000.

This page cited from article: Yael Waknine . FDA Approvals: LTU-904, ORTHO T. cruzi, Paragon Z CRT. Medscape. Dec 18, 2006.

• Fibromyalgia
• Neck and back pain
• Injuries (achilles, sprains & swelling)
• Post-surgery (stiffness & scar-tissue - particularly after mastectomy)
• Fluid retention
• Rosacea
• Lack of energy
• Acne scars (products may be recommended/needed)
• Facial discolouration