Mistral xLHE: the only platform that combines OPT, SHAL and LHE

Mistral xLHE is the only platform that combines LHE, OPT & SHAL in it’s delivery arsenal.

Keep your customers coming back with the most advance aesthetics equipment in the industry.

 The patented technology is a proprietary alternative to IPL and Laser developed by an award winning Physicist in Radiancy Israel.

SHAL is Radiancy’s proprietary algorithm that works with LHE to allow heat to be delivered to the targeted tissue without damaging healthy cells.

 OPT is called many names but it’s a technology that is well used in the aesthetic industry. OPT is typically applied with other technologies.

Radiancy’s xLHE platform combines 3 amalgamates 3 pieces technology to deliver effective and quick aesthetic treatments safely. Here’s a chart of how hair removal is delivered using the 3 technologies. OPT & SHAL delivers 3 rapid LHE pulses to remove hair without the need to shave or use gel on the treated area.




Mistral™-A New Light and Heat Energy (xLHE®) System for Multiple Aesthetic and Dermatological Applications System for Multiple Aesthetic and Dermatological Applications
Dr. Rothman Julia; Mr. Raif Joshua. Radiancy Clinical Department, Hod Hasharon , Israel .
Abstract Light-based systems have made significant inroads into the field of dermatology and aesthetics, becoming the standard treatment tools for a wide range of applications. Various lasers and non-laser light devices are currently approved and clinically applied for indications such as hair removal, photo rejuvenation, vascular and pigmented lesions, tattoo removal, leg veins, acne and psoriasis. In most of these applications, light energy is transformed to thermal energy in the absorbing chromophore. XLHE technology combines the application of light energy with an additional source of direct heat energy. This paper describes Radiancy’s new x-Light and Heat Energy (xLHE) system, Mistral, and summarizes the latest clinical results using this unique technology. Introduction Light-based systems have, over the past 20 years, made significant inroads into the field of dermatology and aesthetics. The range of systems offered, as well as the range of clinical applications for which they are being used, is constantly and rapidly expanding. Most of these systems are based on the theory of Selective Photothermolysis, first published by Anderson & Parrish in 1983 (1). This theory defines the optimal wavelength and pulse duration required to achieve a desired effect on dermatological lesions with minimal effect to surrounding tissue. Based on this theory, products such as the pulsed dye laser (PDL) and Q switched Ruby laser were developed and became widely used by dermatologists for the treatment of port-winestains, pigmented lesions and tattoo removal. While clinically effective for a wide range of dermatological applications, varying today from leg veins to hair removal, lasers are monochromatic, emitting a single wavelength. Therefore, different laser systems are required for different clinical applications. To overcome this limitation, Intense Pulsed Light (IPL) systems were introduced in the mid 90’s. These systems emit a broad spectral range of wavelengths, which can be filtered to optimize the desired clinical effect. A single IPL system can be used for several different dermatological applications by changing filters and pulse durations. Current IPL systems usually come standard with several light-emitting “heads”, each optimized for a different clinical application. Light and Heat Energy (XLHE) XLHE was born from the theory of Selective Photothermolysis itself. As the name implies, this theory deals with selective destruction (lysis) of human tissue by heat (thermo) generated by absorption of light (photo). While lasers and IPL devices use only light to generate heat, thus requiring high light fluences, XLHE technology uses a combination of lower fluence light with direct heat to safely and efficiently implement the concepts of Selective Photothermolysis in a wide range of clinical applications. This streamlined the design and production and took non-laser, light-based dermatological phototherapy one-step further towards affordability by a much wider base of physicians and aesthetics providers. The Mistral System The Mistral XLHE system by Radiancy is a compact, tabletop device that utilizes low fluence flash lamps, which emit light of 350-1200 nm. The treatment heads direct both light and heat towards a particularly large aperture. The aperture defines an effective treatment area of up to 18.5 cm2. Small area adaptors, which reduce the spot size down to 4.2 cm2, may be fitted over the aperture for situations where smaller treatment areas are required. Mistral emits light fluences of up to 15 J/cm2 at repetition rates of 2-4 seconds in between pulses. A range of eight treatment heads is offered with the Mistral for different clinical applications and different patient skin types. These differ in both the spectral and temporal characteristics of the light output, in order to maximize clinical efficacy and assure patient safety. Contrary to previously available XLHE systems, the Mistral emits a rapid train of pulses with intervals optimized for different clinical situations. Fig 1-The Mistral XLHE® System XLHE Hair Removal The dual light and heat energy (XLHE) concept for hair removal is based on the fact that follicle damage can be more efficiently achieved by combining the effects of selective light absorption in follicular melanin with direct conduction of heat through the hair shaft down to the follicle. Light energy absorption occurs in epidermal melanin as well as in hair melanin; however the temporal characteristics of these mechanisms are quite different. The epidermis, being a thin layer with a greater surface to mass ratio than the hair follicle, possesses a low thermal relaxation time in the range of 3-7 msec. The hair follicle, in contrast, has a longer thermal relaxation time in the order of 30-100 msec. For hair removal the Mistral utilizes this difference by emitting the light in a special pulse algorithm that allows the epidermis to dissipate its absorbed energy while the follicle retains the light energy and transform it to the required increase in follicle temperature. Following the light pulse, the Mistral delivers a heat pulse to both the epidermis and the hair shaft. This combined light and heat energy achieves follicular necrosis while sparing surrounding skin from adverse effect . As with any laser or IPL hair removal treatment, initial system settings are based on manufacturer’s recommendations or user’s experience, for a particular patient’s skin type, hair color, coarseness and density. These settings are then confirmed or modified through a series of test spots conducted preferably 24-48 hours before treatment. Optimal settings are judged by the thermal effect on the hair, by surrounding perifollicular erythema and by the lack of any adverse side effects such as marked erythema in the shape of the aperture or blistering. For full hair reduction results, multiple treatments are performed on each site at intervals of 3-weeks to 3 months, depending on hair regrowth. Up to 10 treatment sessions may be required for maximum hair reduction. If regrown hair becomes thinner and lighter treatment parameters will have to be increased in order to reach the desired clinical endpoint. XLHE hair removal studies with long-term follow-up have been conducted and published. Adatto (2) studied 21 patients of skin type II & III with dark, coarse hair mainly on the back or chest for males and the bikini/axilla area for females. Average clinical percentage of hair reduction at 3-6 months after the last treatment session was 58% for males and 73% for females. As expected, the anatomical sites treated on females respond better than those treated on males and require, on average, fewer sessions (5.53 vs. 7.5). Side effects were all minor, transient, and included erythema for up to two days and few crusted areas where hair was very dark and coarse. These crusts fell off within a few days with no dyspigmentation of the skin. XLHE hair removal on patients with skin type I-IV is typically conducted with the regular hair removal treatment head which emits a spectrum of 400-1200nm. For darker skin types a longer wavelength, sensitive skin, treatment head is available. Sadick & Krespi (3) studied the efficacy and safety of this treatment head on 26 subjects with Fitzpatrick skin types V & VI. Fifty seven (57) sites were treated once and were followed up for 3 months. Average hair clearance of 41.7% was found at the 6 week follow-up visit and an average of 35.5% clearance was found at the 12-week follow-up. Besides mild and transient edema in two patients and erythema in eleven patients, one patient had a burn which resulted in crusting and hypopigmentation while another four patients developed hyper or hypopigmentation. At the 12-week follow -up all cases of hypopigmentation were resolved while the hyperpigmentation cases were still present but reduced to a mild form. Hydroquinone cream was prescribed for these cases. average improvement of 62.5% (3 on a scale of 4) was achieved. For patients with primary indication of vascular lesions, an average improvement of 45.2% (2.3 out of 4) was Baseline 1 month after 3Tx Fig 2-XLHE® Hair Removal Z.G.33y, ST II XLHE Photorejuvenation Photo rejuvenation is a non-invasive, no downtime technique for the treatment of photodamaged, aged skin. Using a broad spectrum of wavelengths in addition to direct heat, XLHE technology can eliminate pigmented sun damage and small, visible, blood vessels, while simultaneously initiating neo-collagenesis as a result of a mild thermal insult to dermal collagen. Adatto & Lima (4) studied XLHE photo rejuvenation on 16 female subjects representing 23 locations which included face, neck, chest and hands with varying degrees of photodamage. Results were assessed by comparing digital photographs of patients taken before and after treatment. Reduction in skin pigmentation was 2.85 on a scale of 4. Improvement in vascular lesions was 2 on a scale of 4. Clinical improvement in skin texture was difficult to quantify although diminution of fine wrinkles was evident and neo-collagenesis was demonstrated in skin biopsy specimens. No scarring, hyper or hypo-pigmentation was observed . In a multicenter study (5) 99 patients, mostly females, of Fitzpatrick skin types I-V and mean age 52.4 years were treated for photorejuvenation. In most of these patients (65.5%) solar lentigines was the primary indication. For these patients an obtained. Clinical improvement was also seen in skin texture but was difficult to quantify. All patients had transient erythema after each treatment, which resolved within 2-12 hours. Pigmented lesions darkened a few minutes after the treatment and exfoliated within a few days. Superficial crusting was the most common side effect occurring in almost 30% of the patients. Only one patient experienced transient hypopigmentation while another patient (skin type IV) experienced hyperpigmentation, which lasted 2 months and disappeared following treatment with hydroquinone 4% cream. Three patients had blistering but no permanent scarring occurred. Morel (6) reported on twenty patients treated for photo rejuvenation with XLHE. For sun damage pigmentation the average number of treatment sessions was 2.5 (range 1 to 4) and follow-up was up to 6 months. There were no significant adverse effects. All patients experienced temporary erythema and immediate darkening of pigmented spots. Superficial crusting resolved within 7-10 days. Two patients had partial blistering. Lightening of pigmented lesions was observed after the first treatment session and improved with further treatments. While objective evaluation of wrinkle improvement was not possible, patients did experience an improvement in skin texture and skin tone . Baseline 1 month after 1Tx Fig 3-XLHE® Sun Spot treatment .32y, ST II Baseline 1 month after 1Tx Fig 4-XLHE® Skin Texture treatment .29y, ST III XLHE Acne Treatment The Mistral Acne treatment head emits a 35 msec pulse of 430-1100 nm at an optical fluence of 315 J/cm². This combined light and heat energy pulse utilizes several photo thermal principles, which are known to have a positive effect in the treatment of inflammatory acne. The emitted light wavelengths accommodate well for photo excitation of endogenous porphyrins produced by P. acne bacteria and for the coagulation of blood vessels that surround the acne lesions while the pulse of heat contributes to anti-inflammatory reactions and sooths the painful lesions associated with acne. The additional heat also speeds up the reaction time and intensifies the basic chemical process associated with the release of singlet oxygen from the photo-excited porphyrins (7). evaluate the safety and effectiveness of XLHE for the treatment of mild to severe inflammatory acne vulgaris (8). The study included three phases: control period, treatment period and follow-up period. The patients served as their own control by foregoing any method of treatment for a period of 4 weeks. After completion of the control period, the patients were treated twice a week for a period of 4 weeks. Follow-up for safety and effectiveness evaluations were performed following each one of the treatments and 4 weeks following the last treatment. Patients with mild to severe acne were enrolled in the study but only pustules and papules (inflamed lesions) were assessed for efficacy evaluation. Before treatment, the area was thoroughly cleaned and dried Based upon a pre-treatment test, the highest power level that showed no side effects was used for treatment. After covering the entire area, the clinicians waited 5 minutes to allow the skin to cool down, and repeated the procedure one more time . In total, in 75% of the treated areas, 50% or greater reduction in inflamed lesions was recorded following the treatment regimen, while no such improvement was achieved following the control period. Following the follow-up phase, a mean reduction of 60.2% was achieved as compared to an increase of 32.4% measured after the control phase . Erythema was the only side effect reported and in all cases, it was minimal and transient. Patients are spared the risks associated with exposure to antibiotic acne medications. Zimmerman’s (9) experience with XLHE for the treatment of mild to moderate acne confirms these published results. In a group of eleven patients (age 13 to 27, 6 females 5 males) he documented the number of non-inflamed and the number of inflamed acne lesions over a 4-week treatment period. On average, non-inflamed lesion clearance of 58.4% and inflamed lesion clearance of 76.5% were observed. On all eleven patients, an inflamed lesion clearance of at least 50% was obtained. Side effects were minimal and included mild erythema in three patients and mild crusting in one. Overall, patient satisfaction with these results was high . the skin and maintaining the psoriatic plaque. Selective photothermolysis of the dermal vasculature using a 585nm pulsed dye laser (PDL) has been demonstrated and has been cleared by the FDA. XLHE is potentially a more effective treatment for psoriasis since in addition to green and yellow light for the coagulation of the psoriatic capillaries, this non-laser system also emits a pulse of heat, which reduces swelling and inflammation and relieves itching . An intra-patient controlled study on the use of XLHE for the treatment of mild to moderate psoriasis has been published (10). In this study, 13 patients received two therapy regimens on similar psoriatic lesions or on two sides of the same lesion. One regimen included ten biweekly XLHE treatments combined with daily application of 20% salicylic acid while the second, control regimen, included daily salicylic acid only. Efficacy of the treatment was assessed using the Psoriasis Severity Index (PSI) calculated from the investigator’s overall assessment of the plaque’s erythema, scaling and induration. PSI was evaluated at baseline, at every other treatment visit and at two follow-up visits conducted 1 and 5 weeks following the last treatment visit. In most cases, a fluence level of 8.6 J/cm² was found to be the most effective and safest treatment parameter. Of the 11 patients who completed the treatment regimen, only one had a poor response (12.5% reduction in global PSI). Ten of the patients Baseline 2 months after 8 bi-weekly Tx Fig 5-XLHE® Acne Clearance XLHE Psoriasis Treatment In psoriasis, the earliest observable electron microscopic changes are in the dermal papillary vasculature. These vessels have been implicated as participating in the pathogenesis of the disease by facilitating the access of activated T cells to (91%) had a 50% or above reduction in their PSI score while six (55%) had a significant improvement of 70% reduction or above. In contrast, on the control sites average global PSI score was reduced by only7.4%. Side effects included erythema, in all cases, which resolved within 24-48 hours and six cases of burns, which resolved, following appropriate remedy, within 2 days to 2 weeks. The clinical results obtained with the XLHE system in this study were remarkably similar to those previously reported with the pulsed dye laser. Zimmerman (9) studied a group of 29 patients (17 males, 12 females) in which individual plaque psoriasis lesions from 3×2 cm. to 14×12 cm. were designated for treatment. Lesions were located on the elbow, knee, foot, belly, forearm and thigh. Lesions underwent an average of 9.8 treatment sessions (range 6-16). In each visit scaling, erythema and induration were assessed on a 0-4 scale and an SEI score was documented. At the end of treatments, average SEI score reduction was 60.3%. Clearance of 50% or above was achieved in 24 of the 29 treated lesions (83%). Size and shape of the treated lesions remained unchanged. Treatment fluence was in the range of 6-7 J/cm2 . Higher fluences may be even more effective but are too uncomfortable for the patients . Baseline 5 days after 1Tx Fig 6-XLHE® Psoriasis Care XLHE Photodynamic Therapy To enhance the photodynamic reaction in acne phototherapy and potentially treat moderate to severe inflammatory acne, some investigators have began to use an exogenous form of PDT in which 5-Aminolevulinic acid (ALA) is topically applied to the area for 30 minutes before XLHE activation. Gold (11) reported on the use of this technique on twenty patients with moderate to severe acne lesions. Patients received one treatment per week for 4 weeks. Five patients were lost to follow-up and three did not respond. Of the remaining twelve patients, reduction in acne lesions was 71.8% 12 weeks after final treatment. Gaboriau (12) also reported on the use of XLHE PDT for the treatment of actinic keratosis, Bowen’s disease and photoaging-related skin changes in situations where the condition is more severe and the patient is willing to be out of the sun and bright light for 48 hours. In summary The Light and Heat Energy (XLHE) based Mistral is a compact, simple to operate and cost-effective system which is applicable for a wide range of dermatological and aesthetic applications. These include hair removal, elimination of superficial pigmented lesions and superficial vascular lesions, photo rejuvenation of sun damaged, aged skin and phototherapy of acne and psoriasis lesions. Use of this system for the treatment of keloid scars has also been reported (12,13) resulting in softening and some flattening of the scar as well as marked diminution of the erythema. These different applications are afforded by attaching different handpiece assemblies to the same basic system. The operation of the system is extremely simple, treatment is fast due to the large spot size and high repetition rate, and patients usually experience only mild discomfort with no convalescence downtime.
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2.Adatto MA: Hair removal with a combined light/heat-based photo-epilation system: a 6month follow-up. J. Cosmetic & Laser Ther 2003;5:163-167.
3.Sadick NS, Krespi MD: Hair Removal for Fitzpatrick Skin Types V and VI Using Light and Heat Energy Technology. J. Drugs in Dermatology, Sept 2006, Vol 5, No 8, pp 724-6.
4.Adatto MA, Lima HRB : Photorejuvenation with a New Light/Heat-Based Energy Device: A Preliminary Study. Cosmetic Dermatology, Jan 2005, Vol 18 No 1, pp 53 -63.
5.Adatto MA et al : Results of Non-Ablative Photorejuvenation with a New Device Using Light and Heat Energy (XLHE®): A Multi-Center Study. ASLMS poster presentation, April 2004.
6. Morel J-L,: Technologie XLHE™ (Energie Lumineuse et Thermique)-Une approche originale du rajeunissement non ablative cutane. AFME Bulletin Trimestriel Nov 2004.
7. Elman M, Lask G: The role of pulsed light and heat energy (XLHE) in acne clearance. J. Cosmetic Laser Ther. 2004 Jun;6(2):91-5.
8. Gregory AN, et al: A Study on the Use of a Novel Light and Heat Energy System to Treat Acne Vulgaris. Cosmetic Dermatology Vol. 17 No. 5 May 2004.
9. Zimmerman J.: Dermatologische Indikationen fur die Behandlung mit Kombinierter Licht-und Warmeenergie (XLHE Light Heat Energy). Asthetische Dermatologie 3/2005.
10. Leviav A, Wolf R, Vilan A: Treatment of psoriasis with light and heat energy (XLHE): a preliminary study. Dermatology Online J. 2004 Oct 15;10(2):4.
11. Gold MH et al : The Use of a Novel Intense Pulsed Light and Heat Source and ALA-PDT in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris. J Drug Dermatol 2004; 3(6): S15-S16.
12. Gaboriau HP: Skin Rejuvenation with the SkinStation. Cosmetic Dermatology, Oct 2006, Vol 19 No 10, pp 642-647 . 13. Levenberg A.: Treatment of a Mediastinoscopy-Induced Keloid with a Pulsed Light and Heat Energy Device. Cosmetic Dermatology, July 2004, Vol 17 No 7 pp 445-7

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