Ltu-904 Laser

[Verona Garrott]

TheRianCorp LTU-904 is the only laser device that has been cleared by the FDA for lymphedema treatment after cancer. This lightweight low-level laser offers a painless solution for the treatment of post-mastectomy lymphedema.

The RianCorp LTU-904 is a low-level laser device. The handheld laser is an infra-red laser that operates at a wavelength of 904 nanometers. The wavelength penetrates deeply into tissue and produces a photochemical reaction at a cellular level. When the laser light from the low level laser penetrates tissue, the light is absorbed by cells and converted into energy that affects metabolic processes.

Low Level Laser therapy (LLLT) is the treatment of various conditions using laser to bring about a photochemical reaction at a cellular level. The laser light penetrates into tissue where it is absorbed by cells and converted into energy that influences the course of metabolic processes.

The LTU-904 is an infrared laser operating at a wavelength of 904 nanometers. This invisible wavelength penetrates deeply into tissue (much deeper than the often used red laser operating in the visible red region).

Cleared by the 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 postmastectomy lymphedema.

Each unit (excluding to USA) comes with a reflective shield. This innovation ensures that light reflected from the surface of the skin is reflected back to the tissue. This improves the effectiveness of the unit.

The LTU has a self contained power supply of rechargeable nickel metal hydride batteries. Each unit comes with an ac adaptor/battery charger to suit your country, reflective shield (excluding to USA), instruction manual, infra-red indicator and carry case. The entire package is light weight and completely portable.

Infra-red energy is absorbed in the cell membrane, where it induces a photophysical reaction which directly mediates the membrane potential, resulting in the intra and extra cellular transport of photoproducts.

The cellular mechanisms are immediate, and are followed by secondary local reactions as the photoproducts interact with surrounding cells and tissue, producing such documented effects as enhanced blood and lymphatic flow, and photomediated neural responses. The local reactions are followed by systemic effects as the photoproducts are carried by the blood and lymphatic systems around the body, and the photomediated neuroresponses take effect.

LLLT uses a laser to bring about a photochemical reaction at a cellular level. The laser light penetrates into tissue where it is absorbed by cells and converted into energy that influences the course of metabolic processes.

We are pleased to announce that LTU-904, an innovative low level laser treatment of SciGen, the member of Yifan International Group dedicating to commercialize innovative therapies worldwide, will be launched to Korean market.

LTU-904, developed by RianCorp, an Australian medical device company dedicating to the development & production of medical laser products for photochemical applications in the field of Low-Level Laser Therapy (LLLT). In June 2021, SciGen entered into the distribution agreement with RianCorp of the novel therapy in Korea. According to the agreement, SciGen is responsible for the registration of LTU-904 in Korea and Post-Approval Marketing Activities. The product is approved by the Ministry of Food and Drug Safety (MFDS) in December 2022.

When indicated for specific conditions, we incorporate LTU-904 Infra-Red Laser Therapy as part of our treatment. This low level laser brings about a photochemical reaction at a cellular level. The laser light penetrates into tissue where it is absorbed by cells and converted into energy that influences the course of metabolic processes.

LTU Infra-Red Laser Therapy is painless and will often bring an immediate analgesic effect at the time of treatment. It dramatically shortens recovery time with rapid reduction of swelling and inflammation.

The frequency and the duration of the treatment will depend on the type of injury and its severity. Treatments can vary from one short treatment session lasting a few minutes, up to several treatments of longer duration.

Cleared by the 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 postmastectomy lymphedema. The LTU-904 is the ONLY laser device cleared by FDA for lymphedema treatment.

Low-level laser therapy (LLLT) is a conservative therapy utilizing nonionizing light sources that has been used in the treatment of lymphedema for breast cancer patients [4]. Studies have shown benefits using LLLT in this population [23,24,25,26,27], with proposed mechanisms of action supporting use of this device on human tissues. The basic mechanism for the use of low-level light for therapeutic benefit includes light absorption, targeting and activating cytochrome c oxidase in the mitochondrial membrane, leading to greater consumption of cellular oxygen and ultimately increased metabolic energy production [28], which is used for cellular repair. Research on the use of this laser at low-intensity wavelengths suggest effects at the cellular level [29] with increased lymphangiogenesis [30] and stimulation of lymphatic motoricity [31, 32] facilitating removal of excess protein-rich fluid, and stimulation of macrophage cells and the immune system [30, 33] which decrease the risk of infection. Studies have reported LLLT to be effective in softening fibrous tissue [4, 32] and surgical scars [34], reducing pain [4, 34], reducing arm volume [34,35,36], and improving QOL in the breast cancer population [33]. Long-term benefits have been documented in the literature using LLLT in this population in limited studies [32, 33, 35, 36], with a 12-month follow-up in one study [35], and a 2.5 year follow-up in one study [32]. In November 2006, the Food and Drug Administration approved the use of the RianCorp LTU-904 low-level laser (LLL) for treatment of post-mastectomy lymphedema [37]. Published studies on the effectiveness of LLLT are currently limited due to lack of research design involving double-blind and placebo-control randomization. In addition, there are limited published studies on the effectiveness of LLLT as a complementary treatment to the standard care of CDT for breast cancer survivors. Thus, the purpose of the study was to evaluate whether the use of LLLT as a complementary treatment to CDT would result in additional improvement and long-term benefits to individuals with lymphedema. The primary outcomes were lymphedema symptoms, limb volume, and QOL. We hypothesized that more patients in the active laser group would have fewer symptoms and less symptom distress, better limb volume, and greater treatment adherence than patients in the inactive laser group.

This study was approved by the Institutional Review Board (IRB) of a larger metropolitan health system and was registered as clinical trial #10-00923. Physicians and nurse practitioners referred potential participants from March 2011, to June 2016. To be enrolled in the trial, potential participants who were willing to participate in the trial had to (1) meet the inclusion and exclusion criteria (Table 1) and (2) obtain written approval from their referring physician, who agreed to allow the patient to participate in the trial.

A double-blind, randomized, placebo-controlled design was used for this pilot study to explore the effectiveness of LLLT on lymphedema as a complementary intervention to CDT when compared with CDT treatment alone. The primary outcomes were lymphedema symptoms, limb volume, and QOL. We hypothesized that patients in the active laser group would have significantly fewer symptoms, better limb volume, and improved QOL in comparison with those in the inactive laser group.

Oncologists affiliated with the medical center were informed about the trial. Women who came to the clinic for a lymphedema evaluation were offered a study flyer for participation into the trial. Fifty-four women who met the inclusion criteria were identified. Twenty-two women agreed to participate in the study. Informed consent was obtained from all participants, and subjects were randomized into either an active laser group or an inactive laser group. One subject consented to the study and was randomized, then changed her mind before data collection was performed, so a total of twenty-one women participated in the study (Fig. 1).

Since CDT has been the standard treatment for breast cancer-related lymphedema (BCRL) [6], all study participants received CDT in this trial. The detailed description of CDT can be found in Table 2. The use of LLL (the LTU-904 laser by RianCorp) was added to CDT. The study utilized a total of 4 lasers, 2 active and 2 inactive laser devices, which were pre-calibrated to provide either active or placebo laser treatment. This information was blinded to participants, lymphedema therapists, and researchers who evaluated outcome measures. Lymphedema therapists were trained in the application of the LLL, and complementary LLLT was administered twice a week at the beginning of each lymphedema treatment session before CDT.

Members of the research team who were blind to the randomization of the LLL device collected data. Lymphedema therapists were trained in the application of LLLT. Both groups received individualized CDT as determined by their treating therapist. Treatment sessions using LLLT as an adjunct to CDT ranged between 8 and 16 sessions, with the final number of visits for each subject determined by the time needed to achieve maximal circumferential reduction as assessed by girth measurements, and palpation of soft tissue texture/density improvement. Demographic and medical information was obtained at the first visit after evaluation. Data collection of selected outcome measures was performed at the first visit after evaluation, after 8 treatment sessions, after the final treatment session, and at long-term follow-up at 3, 6, and 12 months (Table 3). We followed the research procedures used in our prior studies [38, 39], including use of the perometer as recommended by the manufacturers [38,39,40]. Protection of human subjects was ensured by following the guidelines set forth by the IRB. Each participant signed the written consent to the study.

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