A literature review focuses on the following questions:
– Does the device achieve its intended purpose?
– Is the device safe for its intended purpose or purposes?
Clinical Validation of the Model UVL1500 UVLrx Treatment System™
By assessing the clinical literature, a foundation is established for the Model UVL1500 UVLrx Treatment System™. We can delineate the important therapeutic wavelengths for achieving very specific clinical outcomes and validate our specific treatment protocols. From there, we are able to build a strong clinical framework for the Model UVL1500 UVLrx Treatment System™, identifying medical conditions most impacted by the treatment and pursuing the clinical studies to validate the device’s utility.
|Literature Abstracts||Journal and Date||Abstract Body|
|Changes in the surface and activation of circulating leukocytes after autologous transfusion of UV-irradiated blood.||Vestn Khir Im I Grek. 1990 Jun;144(6):99-105.||Under study was the dynamics of functional properties of leukocytes of healthy people and patients after UV-irradiation of their blood, mixing the UV-irradiated and non-irradiated blood. It was shown that UV-irradiation and mixing the irradiated and non-irradiated blood facilitated the liberation of bactericidal cation proteins of leukocytes, higher expression of membrane receptors, growth factors, activation of reparation of DNA after its injury by gamma-rays. It proves the role of immediate activation of leukocytes of the circulating blood in trigger mechanisms of effects of autotransfusion of UV-irradiated blood.|
|Intravascular laser irradiation of the blood in the treatment of patients with surgical infection.||Vestn Khir Im I I Grek. 1989 Sep;143(9):48-51||The intravascular laser irradiation of blood which was used in treatment of 100 patients decreases the level of endogenous intoxication, stimulates the defensive forces of the organism, improves the condition of the patient, contributes to quicker recovery and may be actively used in treatment of patients with a surgical infection.|
|Changes in the oxygen balance of the body in the acute period of hemorrhagic shock and after resuscitation under the effect of intravascular helium-neon laser irradiation of the blood.||Anesteziol Reanimatol. 1994 Sep-Oct;(5):21-5.||The effect of intravascular laser irradiation of the blood (ILIB) on the oxygen budget of the body and blood acid-base balance in the acute period of hemorrhagic shock and after resuscitation was studied in experiments on dogs. Duration of hypotension was 2 h. Laser therapy was started from the 5th-8th min of hypotension and lasted for 45 min; it was performed with a He-Ne laser (ALOK-1, 1 mWt power at the tip of the light guide, wavelength 621 nm) introduced in the right jugular vein. Exposure to ILIB in the acute period of hemorrhagic shock was conducive to creation of favorable conditions for realization of the compensatory mechanisms aimed at improvement of circulation and gas exchange in the lungs, at provision of delivery of oxygen to tissues and its utilization, and, hence, promoted the survival of animals by triggering the regulatory mechanisms of redistribution of the regional bloodflow, improvement of tissue perfusion, and possibly, of oxyhemoglobin dissociation processes in red cells.|
|Endovascular therapy with laser light in the combined treatment of acute pancreatitis.||Khirurgiia (Mosk). 1993 Jan;(1):43-6.||Studies conducted in experiments (132 animals) and in the clinic (109 patients) revealed a close relationship between the severity of pancreatogenous endotoxicosis and red cell membrane hyperlipoperoxidation and spontaneous red cell hemolysis, which allows three degrees of blood red cell lipoperoxidation to be distinguished in the period of acute endotoxemia: mild, moderate, and severe. Inclusion of blood laser irradiation into the management of acute pancreatogenous toxemia in moderate and severe degrees of blood red cell hyperlipoperoxidation reduces authentically the peroxide damage of the red cell membranes and the marked character of hemic hypoxia. The best effect was produced with the use of LG-75-1 laser beam in an elaborated regimen in severe red cell lipoperoxidation. The content of secondary lipoperoxidation products reduces in this case by 28.5% on the average in significant correlation with normalization of some clinical and laboratory parameters.|
|The mechanisms of the therapeutic action and the basis for the frequency of performing sessions of ultraviolet blood irradiation in treating acute pneumonia. 1||Ter Arkh. 1994;66(8):39-42.||Mechanisms of therapeutic action of UV blood irradiation and optimal irradiation scheduling were studied in the course of UV-irradiated blood transfusions capable of correcting lipid peroxidation (LPO) and antioxidant system (AOS) in acute pneumonia (AP) patients. Single and multiple measurements of LPO and AOS parameters (malonic dialdehyde, diene conjugates, red cell resistance to peroxide hemolysis, catalase, superoxide dismutase, cerulloplasmin, plasma total estrogens, progesterone and testosterone) were made in 10 young males with moderate AP and 20 healthy controls. UV blood irradiation in AP is shown to be pathogenetically validated. It works via effective stabilization of LPO as a result of early adequate stimulation of endogenic AOS. Positive changes were also induced in the system of hormonal regulation. It is suggested that hyperestrogenemia plays a compensatory role in AP pathogenesis.|
|The use of the immunomodulating action of intravascular laser irradiation of the blood in treating peptic ulcer patients.||Lik Sprava. 1992 Jan;(1):66-8.||Intravascular laser radiation of the blood was employed in 68 patients with ulcer disease in the complex treatment with antacid; cholinolytic, antioxidant agents. The employment of helium-neon laser as an immunomodulator resulted in an improvement of indices of cellular and humoral immunity, normalization of lipid peroxidation, increased resistance of the gastric and duodenal mucosa, reduction of the time of scarring of the ulcer defect against the background of rapid clinical remission, increase of the interrecurrence period.|
|Intravascular laser irradiation of blood in the treatment of patients with lung abscess.||Klin Med (Mosk). 1989 Sep;67(9):35-7.||Intravascular blood laser irradiation has been introduced into a multimodality treatment of pulmonary abscesses in 47 patients. Intracavitary laser irradiation of the abscess or pleural empyema was performed in 10 cases. A suggested detoxication and immunostimulation related to the laser therapy was confirmed. The highest efficacy of the treatment was found for chronic pulmonary abscesses, the least one in decompensation associated with multiorgan failure.|
|Evaluating the efficiency of low level laser therapy (LLLT) in combination with intravenous laser therapy (IVL) on diabetic foot ulcer, added to conventional therapy||JLMS 2010;1:8-13||INTRODUCTION: Low level laser therapy (LLLT) is gaining acceptance in clinical applications. For example, it is used as therapeutic modality in the repair of diabetic foot ulcer when conventional therapy was not effective, separately. The aim of this study is to determine the effect of local and intravenous LLLT for the healing of diabetic foot ulcer. METHODS: This study contains 74 diabetic foot-ulcers which were prone to resistance to conventional therapy. Different stages of diabetic foot are included in this study. The wounds irradiation are performed by the combination therapy of 650 nm and 860 nm laser, with the total energy density of 3.6 J/cm² plus intravenous laser therapy (IVL) with 2.5 MW, 650 nm laser used for 30 minutes. All wounds have been photographed from equal distance, before and after treatments, and all the wounds were staged by a surgeon who was disinterested and neutral about the effects of the laser therapy. Her judgments were based on the visual assessments of the wounds. All the mathematical and statistical analysis is based on the descriptive statistics which, is done by the SPSS 16. RESULTS: in the result of this study; 62.2% (Forty-six out of the 74 ulcers) completely healed, 12.2% (Nine in numbers) healed more than 50%, 8.1% (Six in numbers) healed less than 50%, 5.4% (Four in numbers) not healed,12.2% (Nine in numbers) did not continue their treatment (less than 5 sessions of Laser therapy). Excluding, the wounds in stage 5, more than 80% of each stage’s wound, completely healed more than 50%, with in 2 months duration. In this study, we definitely can express that, all the Patients received some degrees of healing, during their laser receiving treatments. CONCLUSION: The combined local and intravenous LLLT promote the tissue repair process of diabetic foot ulcer. In this multi-disciplinary method, we achieved a remarkably shorter mean healing time of two months, compared with other reported studies with healing time of three to six months.|
|Hemosorption and ultraviolet irradiation of blood in the complex treatment of suppurative and septic diseases in children||Vestn Khir Im I I Grek. 1990 Jun;144(6):79-81.||Data on the observation of 120 children aged from one to seven years with ++pyo-septic diseases are described. The complex of intensive therapy included methods of extracorporal detoxication. Positive dynamics was noted after hemosorption and UV irradiation of blood. Preliminary UV irradiation of blood before sorption eliminated metabolic disorders. Less lethality was noted.|
|The effect of endovascular helium-neon laser therapy on the immune status of patients with acute calculous pyelonephritis.||Urol Nefrol (Mosk). 1996 Nov-Dec;(6):9-11.||Cellular immunity was assessed in 48 patients with acute calculous pyelonephritis exposed to intravenous He-Ne laser therapy. It was found that endovascular He-Ne laser therapy in the study regimens corrects immunological abnormalities arising in acute calculous pyelonephritis.|
|Intravenous laser irradiation of the blood in severe forms of chronic venous insufficiency.||Vestn Khir Im I I Grek. 1992 Jul-Aug;149(7-8):78-80.||Based on an analysis of results of treatment of 86 patients the authors have shown that the intravenous laser irradiation of blood results in hypocoagulation, lower hematocrit index. In 52 patients good results of treatment were obtained, in 26 patients results were satisfactory. No complications were noted.|
|Experience with the use of UV irradiation of autologous blood in oral surgery.||Stomatologiia (Mosk). 1990 May-Jun;69(3):49-50.||Autotransfusions of UV irradiated blood were used in the treatment of 20 patients with grave proinflammatory maxillofacial diseases. 54 sessions were carried out, that resulted in a manifest clinical effect. The results evidence that this method may be effectively used as the main treatment modality in the management of recurrent furunculosis of the face.|
|The mechanism of the action of UV-irradiated autotransfusions in treating patients with suppurative-inflammatory diseases of the face and neck.||Vestn Khir Im I I Grek. 1989 Oct;143(10):92-4.||An analysis of examination and treatment of 36 patients with acute pyo-inflammatory diseases of face and neck has shown the inclusion of UV-irradiated autotransfusions into the complex of therapeutic measures to decrease blood viscosity and to increase deformability of erythrocytes. It elevates the intensity of blood circulation in the system of macro- and microcirculation. The increased arteriovenous oxygen difference after UV-irradiated autotransfusions points to improved utilization of tissue blood and enhanced bioenergetic processes.|
|The choice of the method for intravascular laser therapy in rheumatoid arthritis.||Ter Arkh. 1994;66(1):29-32.||A randomized placebo-controlled study was made of the clinical efficacy of four different methods of intravascular laser blood irradiation (ILBI) with helium-neon laser in 150 patients suffering from rheumatoid arthritis (RA). As to ILBI methods used, the most remarkable clinical effect was produced by daily procedures. The positive effect of ILBI was of liminal character bearing in mind the power range examined whereas the negative effect of irradiation was dose-dependent. ILBI may cause an exacerbation of the inflammatory process in RA whatever the single dose and frequency of procedures. The best clinical effect with daily ILBI was attained in women, individuals with the presence of rheumatoid factor but with low titers thereof, and in patients with initial stages of RA and minimum inflammation activity. The efficacy of ILBI may be predicted on the basis of the patient’s clinical findings.|