Sirius eBook

SiriusTM Innovative solutions for face and body eBook



Dear reader, On behalf of Candela, we would like to thank you for your interest in the Sirius™ system, a multi-application platform with patented, narrowband SWT® - Selective Waveband Technology® - with dual filters for photorejuvenation, hair removal, and facial veins.1 In this eBook, we provide you with the most important information regarding this device, from technology overview to results clinical experts worldwide have achieved with their patients. Know that when you decide to work with one or more of our devices, we’ll do everything we can to provide you with the highest level of customer service possible. That’s our promise to you. The Candela Marketing Team 1. Sirius, CE mark.

Science. What can you treat? Unique IPL with narrowband technology defined by dual filters for exceptional photorejuvenation and vascular treatments, as well as hair removal.1,2 6 01 Hair removal indications1,2,3 02 Photorejuvenation (via vascular + pigmented lesions) 03 Telangiectasia 04 Benign pigmented lesions (mottled pigmentation, ephilides) 05 Benign vascular lesions (diffuse redness) 06 Poikiloderma of Civatte 1. Sirius CE Mark. 2. Sirius system instructions for use, 2019. Candela, data on file. 4

Science. Patient advantages: Give your patients what they want: The assurance of proven results. With 20 years of clinical experience, the Sirius system is one of the most proven multi- application systems available in the market 01 today. Safety. The SWT® - Selective Waveband Technology® rejuvenates your sun-damaged skin and makes it look clear and bright by 02 delivering short bursts of light that directly target the blood vessels or melanin within your skin. Potentially harmful wavelengths are removed using patented Dual Mode Filtering.1 03 Comfort. No topical anesthetics are required, and many patients describe the treatment as being like a flick from a rubber band snapping onto the skin. 04 Fewer treatments. Fewer treatments compared to other IPL procedures2. 05 Short and few treatment sessions. A treatment could take about 20 minutes, depending on the area of the face or body that you want treated. You should see an improvement after the first treatment, but up to 3 treatments may be required to achieve the 1. Candela, Data on File, 2019 full effect. 2. Bjerring P, Christiansen K, Troilius A. Intense pulsed light source for treatment of facial telangiectasias. J Cosmet Laser Ther. 2001;3(4):169-173. 5

Science. Practice advantages: Let the Sirius system open the doors to the lucrative hair removal and skin rejuvenation* markets. The Sirius system is an intense pulsed light (IPL) platform. The 5 applicators (HR 600, HRL 600, HRD 645, VL 555, VLS 555) available on the device use SWT®, a narrowband, intense pulsed light technology minimizing risk by eliminating extraneous broadband light.1 With its easy learning curve, pre-programmed treatment settings, and complimentary training provided by Candela, the Sirius system sets the stage to quickly accelerate your practice offerings. The Sirius system is the perfect, affordable, multi-application platform. Key reasons to introduce Sirius into your practice. Provides solutions for the most in-demand treatments 5 handpiece options for a variety of treatments Guided mode with user pre-sets for easy learning Touch screen technology for selecting treatments and parameters Built-in patient database stores and retrieves treatment information Quiet and ergonomic operation Remote assistance for enhanced serviceability * As defined by reduction in skin redness. 1. Sirius, CE mark 6

Science. Mechanism of action | Sirius™ The Sirius system delivers narrower wavelengths, less fluence, fewer treatments. The Sirius system with the SWT® technology uses narrower wavelength bands, per condition, which enables treatment of photodamaged skin using less than half the fluence and no active cooling, and requiring fewer treatments than reported in studies with broadband IPL devices. On Sirius, SWT applicators come in 5 narrowband versions. The SWT® technology uses exclusive selective wavelength technology with dual filters to deliver narrowband IPL to the target tissue, filtering out any potentially harmful wavelengths. Treat smaller areas without affecting the surrounding skin. For photorejuvenation treatments, you have the choice between the VL 555 applicator for overall treatment and the VLS 555 applicator to treat close to and around the eyes and the nose. 7

Results. Photorejuvenation Before After 1 treatment Courtesy of Ellipse Denmark Before After 3 treatments Courtesy of Eduardo Lauzurica, MD - Spain Before After 2 treatments Courtesy of Harue Suzuki, MD - Japan Photos are unretouched. Individual results may vary. 8

Results. Photorejuvenation Before After 3 weeks, 1 session, 3 passes Courtesy of Ioanna Panoutsopoulou, MD - Greece Before After 1 treatment Courtesy of Dermacaribe – Kristian Eichelmann & Martha Garcia, MD - Mexico Before After 3 treatments Courtesy of Prof. Peter Bjerring, MD - Denmark Photos are unretouched. Individual results may vary. 9

Results. Photorejuvenation Before After 1 treatment Courtesy of Ellipse Spain Before After 1 treatment Courtesy of Prof. Agneta Troilius Rubin, MD - Sweden Before After 3 treatments Courtesy of Ben Gehl, MD - Austria Photos are unretouched. Individual results may vary. 10

Results. Photorejuvenation Before After 1 treatment Courtesy of Prof. Agneta Troilius-Rubin, M.D. Before After 1 treatment Courtesy of Ellipse Spain Before After 3 treatments Courtesy of Kei Negishi, M.D. Photos are unretouched. Individual results may vary. 11

Results. Photorejuvenation Before After 1 treatment Courtesy of Kristian Eichelmann & Martha Garcia, M.D. - Mexico Before After treatments Courtesy of Ellipse Spain Photos are unretouched. Individual results may vary. 12

Results. Photorejuvenation Before After 2 treatments Courtesy of Prof. Agneta Troilius-Rubin, M.D. Before After Courtesy of Matthew Mahlberg, M.D. Photos are unretouched. Individual results may vary. 13

Results. Vascular lesions Before After 2 Treatments Courtesy of Prof. Peter Bjerring, M.D. Before After 4 Treatments Courtesy of Eduardo Lauzurica, M.D. Before After 2 treatments Courtesy of Franco Scardigli, MD - Italy Photos are unretouched. Individual results may vary. 14

Results. Vascular lesions Before After 1 treatment Courtesy of Prof. Michael Drosner, MD - Germany Before After treatment Courtesy of Tonegawa, MD - Japan Before After 3 treatments Courtesy of Prof. Peter Bjerring, MD - Denmark Photos are unretouched. Individual results may vary. 15

Results. Hair removal Before After 3 treatments Courtesy of Prof. Peter Bjerring, MD - Denmark Before After 4 treatments Courtesy of Prof. Agneta Troilius Rubin, MD - Sweden Before After 3 treatments Courtesy of Ellipse Denmark Photos are unretouched. Individual results may vary. 16

Results. Hair removal Before After 5 Treatments Courtesy of Fauzia Z Khan, M.D. Before After 3 treatments Courtesy of Prof. Agneta Troilius Rubin, MD - Sweden Before Afte 1 Treatment Courtesy of Forsslund P., R.N. Photos are unretouched. Individual results may vary. 17

Results. Hair removal Before After Courtesy of Fauzia Z Khan, M.D. Before After 3 Treatments Courtesy of Prof. Agneta Troilius-Rubin, M.D. Photos are unretouched. Individual results may vary. 18

Results. Hair removal Before After 4 treatments Courtesy of Prof. Agneta Troilius-Rubin, M.D. Before After treatments Courtesy of Prof. Peter Bjerring, MD - Denmark Photos are unretouched. Individual results may vary. 19

Results. Summary of peer-reviewed articles | The Ellipse IPL Advantage: Improves the appearance of facial telangiectasias Intense Pulsed Light Source for Treatment of Facial Telangiectasias. Study design 24 subjects (19 females, 5 males) with mean age 47.8±9.5 years, Fitzpatrick Skin Types I-III with facial telangiectasias. Results at 2-month follow-up after last treatment: • 100% of subjects showed a reduction in visible vessels: 83.4% had >50% clearance, 66.7% had > 75% clearance • 90.4% of subjects showed a reduction in diffuse erythema • Average cosmetic clearance was 62.7%±23% • Edema developed 1-2 days after treatment and lasted up to 5 days • No purpura, hypertrophic or atrophic scars, or pigmentary disturbances Bjerring P, et al. J Cosmet Laser Ther. 2001 Dec;3:169-73. 20

Results. Summary of peer-reviewed articles | The Ellipse IPL Advantage: A clearance of up to 90% of telangiectasia achieved Progressive Disseminated Essential Telangiectasia and Erythrosis Interfollicularis Colli as Examples for Successful Treatment with a High-Intensity Flashlamp. Study design 4 subjects (3 females, 1 male; mean age 49.3 years) with progressive disseminated essential telangiectasias on the extremities & 5 females (mean age 48.6 years) with erythrosis interfollicularis colli (also known as poikiloderma of Civatte) on the neck/décolletage. Results at 1-month follow-up after last treatment: 21 • 100% of subjects with disseminated essential telangiectasia showed excellent results (76-90% improvement) after multiple treatments (average 2.8) • Subjects with erythrosis interfollicularis colli showed clearance rates of 76-90% (n=2), 51-75%, (n=2) and 26-50% (n=1) after 1-4 treatments • Adverse effects were limited to test spots and didn’t recur after a reduction in energy for treatments • No post treatment intracutaneous hematomas Wenzel SM, et al. Dermatology. 2008 Nov;217:286-90.

Results. Summary of peer-reviewed articles Progressive Disseminated Essential Telangiectasia and Erythrosis Interfollicularis Colli as Examples for Successful Treatment with a High-Intensity Flashlamp Study design • 4 subjects (3 females, 1 male; mean age 49.3 years) with progressive disseminated essential telangiectasias on the extremities • 5 females (mean age 48.6 years) with erythrosis interfollicularis colli (also known as poikiloderma of Civatte) on the neck / décolletage • IPL treatments (555-950 nm): 10x48 mm spot size; fluence 14-17 J/cm2; pulse duration of 14 ms • Photographic evaluation by treating physicians, based on 6-point scale: 0%, 1-25%, 26-50%, 51-75%, 76-90% & >90% Results at 1-month follow-up after last treatment: • 100% of subjects with disseminated essential telangiectasia showed excellent results (76-90% improvement) after multiple treatments (average 2.8) • Subjects with erythrosis interfollicularis colli showed clearance rates of 76-90% (n=2), 51-75% (n=2) and 26-50% (n=1) after 1-4 treatments • Adverse effects were limited to test spots and didn’t recur after a reduction in energy for treatments • No post-treatment intracutaneous hematomas Wenzel SM, et al. Dermatology. 2008;217:286-90 22

Results. Summary of peer-reviewed articles Intense Pulsed Light Source for Treatment of Facial Telangiectasias Study design • 24 subjects (19 females, 5 males) with mean age 47.8±9.5 years, Fitzpatrick Skin Types I-III with facial telangiectasias • 1-4 IPL treatments (555-950 nm) at 1-month intervals: 10x48-mm spot size; fluence 13-22 J/cm2 (mean 17.1±2.0 J/cm2); pulse durations of 10 ms for diffuse redness, 15 ms for visible thin vessels & 30 ms for thick vessels • Blinded clinical and photographic evaluation by 1 independent dermatologist, based on mean result for % clearance of visible vessels and % clearance of diffuse erythema Results at 2-month follow-up after last treatment: • 100% of subjects showed a reduction in visible vessels: 83.4% had >50% clearance, 66.7% had > 75% clearance • 90.4% of subjects showed a reduction in diffuse erythema • Average cosmetic clearance was 62.7%±23% • Edema developed 1-2 days after treatment and lasted up to 5 days • No purpura, hypertrophic or atrophic scars, or pigmentary disturbances Bjerring P, et al. J Cosmet Laser Ther. 2001 Dec;3:169-73. 23

Results. Summary of peer-reviewed articles Photoepilation Results of Axillary Hair in Dark-Skinned Patients by Intense Pulsed Light: Comparison between Different Wavelengths and Pulse Width Study design • 528 Korean women (mean age 28.7 years, range 21-47; skin types II- IV) treated in the axillary area with IPL 600-950 nm (HR applicator): mean fluence 14.9±2.0 J/cm2 and pulse duration of 40 ms (thick hair) and 20 ms (medium hair) • 27 Korean women (mean age 29.9 years, range 21-43; skin types III-IV) treated with IPL 645-950 nm (HR-D applicator) to the axillary area: mean fluence 17.1±0.6 J/cm2 and pulse duration of 50 ms (thick hair) and 25 ms (medium hair) • 4 IPL treatments at 4- to 6-week intervals • Hair counts of 1 cm2 area performed by blinded investigator, using magnified 3x5 inch photographs Results at 9-month follow-up after last treatment: • All subjects showed statistically significant (p<0.001) hair count reduction • Average clearances of 83.4% and 52.8% were achieved by HR-D and HR, respectively; HR-D results significantly higher (p<0.001) • Pain level significantly lower (p<0.05) with HR-D (3.3 vs. 6.5 out of 10) • No adverse effects with HR-D treatment • 1 case of perifollicular hyperpigmentation at 3rd treatment (subject discontinued) & 1 case of mild hypopigmentation at 2nd session (normal skin color at 9-month follow-up) with HR applicator Hee Lee J, et al. Dermatol Surg. 2006 Feb;32:234-40 24

Results. Summary of peer-reviewed articles Hair Removal with a Second Generation Broad Spectrum Intense Pulsed Light Source − A Long-Term Follow-Up Study design • 10 females (mean age 31±9.2 years) with dark blond to dark hair and Fitzpatrick skin types II-IV were treated with 600-950 nm (HR applicator) on both sides of the bikini areas (20 bikini lines) • 4 IPL treatments at 4- to 5-week intervals: 48 x 10 mm spot size, 44.5 ms pulse duration, train of 4 pulses with 10 ms spaced by 1.5 ms intervals, mean fluence 18.3±3.3.0 J/cm2 • Hair counts of a 25 x 25 mm area, using a computer imaging system (Mirror Image Software System) • Subject pain / discomfort with treatment assessed using a visual analog scale (0=no pain to 10=maximally imaginable pain) Results at 4-month & 8-month follow-ups after last treatment: • Average clearances of 74.7% and 80.2% at the 4-month and 8-month follow-ups, respectively; no statistical difference between follow-ups • ~70% of subjects experienced excellent (75-100%) hair reduction • 2 of the subjects suffering from folliculitis at baseline experienced complete improvement after the 1st treatment • All subjects experienced smoother texture of the skin and lighter thinner type of hair after treatment • Thicker hair had a slower response than thinner hair • Average pain score of 3 on the lateral sides and 5 on the medial areas • 2 subjects developed small blisters, which healed within 1 week without scarring. No pigmentary changes Troilius A, Troilius C. J Cutan Laser Ther. 1999 Sep;1:173-8 25

Trust. Don’t take our word. Take it from our customers. “This smart technology is based in an IPL system with a set of different selective narrowband wavelengths, intended for performing vascular, photorejuvenation, and epilation in fair and dark skins, in a fashion as a laser would do, but adding the advantages of Ellipse IPL. Our clinic has grown by opening a new branch in another city. Our success is mainly because of the right decision we took at the very beginning, when we choose Ellipse as our laser technology partner. We have gotten not only an excellent device able to get outstanding results, but also a great team from the company, always beside us to give a hand and help in our professional development.” - Dr. Sebastian Cintolesi, Stetikmed, Anesthesiologist, Medical DirectorVicent Alonso, M.D. Cosmetic Dermatologist, Santiago, Chile “I use the device primarily to treat conditions which are concerning to patients such as facial redness, telangiectasia, and pigmentation. The system is easy to use with a good touchscreen interface without having an overly cumbersome menu system.” - Dr. James Freeman, Dermatologist, Canna Heights, Australia 26

“Both the VL 555 and the HR applicators have been designed with the operator in mind. The quick charging time in between shots, the swivel base, soft flexible cord and defined crystal block allow for easy access to all body areas as well as fast, successful treatments. The HR comes in two sizes allowing treatment times to be reduced drastically. I enjoy using the standard size for smaller areas such as the face, underarms etc.; and the larger applicator for the body. The specific settings associated with these applicators have improved my results considerably and I find treating stubborn patches or finer hairs much easier. The VL 555 is possibly my favourite applicator. It truly is versatile and allows for many concerns to be addressed as well as many skin treatments to be performed. I found it to be a great investment that really has expanded my treatment portfolio.” - Mieke Morgan, Laser Skin Specialist, London, UK 27

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www.candelamedical.com Disclaimer: All contents of this material are for informational purposes only and provided by Candela without warranties of any kind. Healthcare professionals are solely responsible for making their own independent evaluation as to the suitability of any product for any particular purpose and in accordance with country specific regulations. The availability of products and the indications mentioned in this material are subject to the regulatory requirements and product registration status in each country. Refer to your User Manual for your country specific indications. Products and technical specifications may change without notice. Please contact Candela for more details. © 2021 Candela Corporation. This material contains registered and unregistered trademarks, trade-names, service marks and brand names of Candela Corporation and its affiliates. All other trademarks are the property of their respective owners. All rights reserved. PU02078EN, Rev. A 2460