Low-Level Laser Therapy Unit (LTU-904) pain & scarring
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.
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