FotonaSmooth™ XS
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El sistema láser FotonaSmooth™ XS es una opción muy apreciada por los ginecólogos gracias a su capacidad demostrada de realizar una gran variedad de procedimientos no invasivos y sin contacto con mayor comodidad para el paciente, menor tiempo de inactividad y cicatrización más rápida.
En el siguiente Compendio de Estudios Clínicos se encuentran los resúmenes de los estudios científicos publicados que evalúan la efectividad y seguridad de la terapia con láser de Fotona SMOOTH® en ginecología.
El láser perfecto para ginecología
Durante más de 15 años, Fotona ha estado a la vanguardia de la investigación del láser ginecológico, desarrollando tratamientos ginecológicos revolucionarios y mínimamente invasivos basados en las longitudes de onda láser Er:YAG y Nd:YAG más efectivas y de mayor calidad del sector. La culminación de esta extensa actividad de investigación y desarrollo es la plataforma FotonaSmooth™, una línea de láseres ginecológicos no invasivos y sin contacto que proporcionan resultados inigualables en los tratamientos, con una facilidad de uso, seguridad y eficiencia sin igual.
Er:YAG de calidad superior con nuevo modo SMOOTH
La tecnología láser Er:YAG de Fotona es ideal para el tratamiento de lesiones del cuello uterino y la vagina, así como de lesiones, pigmentaciones y neoplasias causadas por el VPH. Gracias a su capacidad única de desinfección, favorece incluso la cicatrización más rápida del tejido infectado.
El láser Er:YAG de alto rendimiento de Fotona permite realizar una ablación precisa sin calentar el tejido circundante. El agua - el cromóforo que es el principal objetivo en los tratamientos de la piel - absorbe muy bien la energía Er:YAG y, por lo tanto, puede vaporizar la piel con una precisión de nivel micrométrico y muy poca conducción térmica.
La tecnología VSP (ancho de pulso variable) patentada por Fotona permite ajustar el láser Er:YAG con precisión desde la ablación caliente hasta la ablación "fría", así como las relaciones térmicas no ablativas. Esto hace que exista una amplia gama de posibilidades para tratamientos no ablativos, como los revolucionarios tratamientos con IntimaLase®, IncontiLase® y RenovaLase® de Fotona, basados en los ajustes patentados del modo SMOOTH.
Diseñado para una mayor facilidad de uso
Alcance la perfección en los resultados clínicos disfrutando a la vez de una velocidad y eficiencia inigualables: el XS de FotonaSmooth™ presenta una interfaz intuitiva y fácil de usar con ajustes preestablecidos de memoria personalizables para ayudarle a trabajar más rápido y de forma más eficaz. Las piezas de mano ginecológicas de diseño profesional, los modos operativos fáciles de ajustar, entre otras muchas características avanzadas, mejoran aún más la precisión y el rendimiento de cada procedimiento para lograr una eficacia clínica óptima y un control incomparable durante los tratamientos.
Tratamientos principales
Accesorios
G-Runner™ Scanner
The G-runner™ scanner is designed for automatic, precise and carefully controlled delivery of laser energy to the vaginal canal for more homogenous coverage of the vaginal mucosa. With procedure-guiding presets and touch control, G-runner eliminates errors and improves patient and operator comfort with all SMOOTH intravaginal procedures.
R09-2G
This multi-functional, collimated Er:YAG handpiece with a 4 mm spot size comes with a detachable and sterilizable tube specifically for gynecological procedures.
Wireless Footswitch
With the wireless footswitch the laser treatment can be initiated within a 10-meter radius of the Fotona laser system, thereby avoiding an unnecessary tangle of cables on the operating room floor. The wireless footswitch is a perfect complement to your Fotona system, providing more freedom of movement during treatments.
R08-Ti
The R08-Ti straight, surgical Er:YAG handpiece has a 0.45 mm spot size at a focal distance determined by its spacer. It is available with or without a removable air/water spray nozzle.
R11 for Gynecology
This straight Er:YAG handpiece has variable spot sizes from 2 to 7 mm and is designed for use with specialized gynecological adapters for performing minimally invasive gynecological procedures.
G-Set
The G-Set contains a laser speculum and angular + circular golden-mirror adapters for use with the PS03 and R11 handpieces. The G-Set is designed for performing minimally invasive gynecological treatments.
SClear Speculum
The SClear Speculum is a transparent, single-use vaginal speculum designed to be used with G-Set for Fotona’s minimally invasive SMOOTH™ laser gynecology treatments such as IntimaLase®, IncontiLase® and RenovaLase®.
PS03X
Medical grade titanium accessories.
Resultados clínicos
Clinical Results
Genitourinary Syndrome of Menopause
Courtesy of: Adrian Gaspar, MD
Laser source: Non-Ablative Er:YAG
Stress Urinary Incontinence Treatment
Courtesy of: Urska B. Ogrinc, MD & Sabina Sencar, MD & Helena Lenasi,
MD
Laser source: Non-Ablative Er:YAG
Vaginal Canal Tightening
Courtesy of: Jorge E. Gaviria P., MD & Jose A. Lanz L., MD
Laser source: Non-Ablative Er:YAG
¿Qué es VSP?
El sistema VSP (pulso cuadrado variable) es una solución patentada para generar pulsos láser cuadrados para una absorción de energía más controlada. La duración de los pulsos puede ajustarse entre 50 y 1500 us, en función de las necesidades del profesional. El sistema de pulsos VSP minimiza la absorción innecesaria de energía láser en los tejidos corporales y ayuda a garantizar el máximo rendimiento y la máxima comodidad del paciente durante los tratamientos con láser.
Investigación científica y clínica
Bibliografía de investigación científica y clínica:
STRESS URINARY INCONTINENCE - IncontiLase®:
Vaginal erbium laser treatment for stress urinary incontinence: A multicenter randomized sham-controlled clinical trial - Read Full Text.
O'Reilly BA, Viereck V, Phillips C, Toozs-Hobson P, Kuhn A, Athanasiou S, Lukanović A, Palmer B, Dahly D, Daykan Y, Cardozo L. Int J Gynaecol Obstet. 2023 Nov 5. doi: 10.1002/ijgo.15222
Efficacy and safety of intraurethral Erbium:YAG laser treatment in women with stress urinary incontinence following failed intravaginal laser therapy: a retrospective study - Read Full Text.
Tseng YL, Su CF. Lasers Med Sci. 2023 Sep 9;38(1):207. doi: 10.1007/s10103-023-03872-5
Comparison of Er:YAG and CO(2) laser therapy for women with stress urinary incontinence - Read Full Text.
Li, P.-C. & Ding, D.-C. Lasers Surg Med. 2023; 1– 9. https://doi.org/10.1002/lsm.23694
Long-Term Improvement in Urinary Incontinence in an Elite Female Athlete Through the Laser Treatment: A Case Report - Read Full Text.
Okui, N., Ikegami, T., Mikic, A.N., Okui, M. & Gaspar, A., Cureus. 2023 Mar 27;15(3):e36730. doi: 10.7759/cureus.36730.
SUI in postmenopausal women: advantages of an intraurethral + intravaginal Er:YAG laser - Read Full Text.
Erel, C.T., Gambacciani, M., Ozcivit Erkan, I.B., Gokmen Inan, N., Hamzaoglu Canbolat, K. & Fidecicchi, T., 2023. Climacteric : the journal of the International Menopause Society, pp.1–7
Erbium Laser Thermo-Therapy for Female Stress Urinary Incontinence – 18 months Follow-up - Read Full Text.
Mikić Novakov, A., Bingold, B. L., Korošec, B., & Vi, Z. (2022). LA&HA - Journal of the Laser and Health Academy, 201–5
First assessment of short-term efficacy of Er:YAG laser treatment on stress urinary incontinence in women: prospective cohort study - Read Full Text.
Fistonić N, Fistonić I, Lukanovič A, Guštek ŠF, Turina IS, Franić D. Climacteric. 2015 Oct;18 Suppl 1:37-42.
Novel minimally invasive laser treatment of urinary incontinence in women - Read Full Text.
Ogrinc UB, Senčar S, Lenasi H. Lasers Surg Med., 2015: 47(9): 689-97.
Effects of laser procedure for female urodynamic stress incontinence on pad weight, urodynamics, and sexual function - Read Full Text.
Tien YV, et al. Tien YW, Hsiao SM, Lee CN, Lin HH. International Urogynecology Journal, 2017, Mar 1;28(3):469-76.
Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women – a pilot study - Read Full Text.
Fistonic N, Fistonic I, Findri Gustek S, Sorta Bilajac Turina I, Franic D, Vizintin Z, Kazic M, Hreljac I, Perhavec T, Lukac M. Lasers in Medical Science, 2016: vol. 31 (4) pp 635-43.
Non-ablative erbium YAG laser for the treatment of type III stress urinary incontinence (intrinsic sphincter deficiency) - Read Full Text.
Gaspar A, Brandi H. Lasers in medical science. 2017 Apr 1;32(3): 685-91.
Baseline ICIQ-UI score, body mass index, age, average birth weight, and perineometry duration as promising predictors of the short-term efficacy of Er:YAG laser treatment in stress urinary incontinent women: A prospective cohort study - Read Full Text.
Fistonić I, Fistonić N. Lasers Surg Med. 2018 Jan 23. doi: 10.1002/lsm.22789
Non-ablative Er:YAG Laser Therapy Effect on Stress Urinary Incontinence Related to Quality of Life and Sexual Function: A Randomized Controlled Trial - Read Full Text.
Blaganje, M., Šćepanović, D., Žgur, L., Verdenik, I., Pajk, F., Lukanović, A. European Journal of Obstetrics & Gynecology and Reproductive Biology 224 (2018):153–158
Comparison between erbium ‑ doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence - Read Full Text.
Okui N. World J Urol. 2019 May;37(5):885-889. doi: 10.1007/s00345-018-2445-x
The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction - Read Full Text.
Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010
Predictive factors for the efficacy of Er:YAG laser treatment of urinary incontinence - Read Full Text.
Erel CT, Inan D, Mut A. Maturitas. 2020 Feb;132:1-6. doi: 10.1016/j.maturitas.2019.11.003
Erbium:YAG laser treatment of female stress urinary incontinence: midterm data - Read Full Text.
Kuszka, A., Gamper, M., Walser, C. et al. Int Urogynecol J 31, 1859–1866 (2020). https://doi.org/10.1007/s00192-019-04148-9
Er:YAG laser treatment of urinary incontinence after failed TOT/TVT procedures - Read Full Text.
Erel, C.T. et al. European journal of obstetrics, gynecology, and reproductive biology (2020), 252, pp.399–403.
Safety of vaginal erbium laser: A review of 113,000 patients treated in the past 8 years - Read Full Text.
Gambacciani M, Cervigni M, Gaspar A, Novakov Mikić A, Gaviria J, Koron N, Vizintin Z. Climacteric. 2020;23(sup1):S28-S32. doi: 10.1080/13697137.2020.1813098
Er:YAG laser in hysterectomized women with stress urinary incontinence: a VELA retrospective cohort, non-inferiority study - Read Full Text.
C. T. Erel, I. Fistonić, M. Gambacciani, Y. Oner & N. Fistonić. Climacteric (2020), 23:sup1, S18-S23
Comparison of urethral sling surgery and non-ablative vaginal Erbium:YAG laser treatment in 327 patients with stress urinary incontinence: a case-matching analysis - Read Full Text.
Okui N, Miyazaki H, Takahashi W, Miyauchi T, Ito C, Okui M, Shigemori K, Miyazaki Y, Vizintin Z, Lukac M. Lasers Med Sci. 2022 Feb;37(1):655-663. doi: 10.1007/s10103-021-03317-x
Vaginal erbium laser for treatment of stress urinary incontinence: optimization of treatment regimen for a sustained long-term effect - Read Full Text.
Gaspar A, Koron N, Silva J, Brandi H. Lasers Med Sci. 2022 Jun;37(4):2157-2164. doi: 10.1007/s10103-021-03474-z
Changes in sexual function and vaginal topography using transperineal ultrasound after vaginal laser treatment for women with stress urinary incontinence - Read Full Text.
Long CY, Wu PC, Chen HS, Lin KL, Loo Z, Liu Y, Wu CH. Sci Rep. 2022 Mar 2;12(1):3435. doi: 10.1038/s41598-022-06601-0
Study of Proliferative Activity of Vaginal Epithelium in Women with Stress Urinary Incontinence Treated by Er:YAG Laser - Read Full Text.
Lapii GA, Yakovleva AY, Neimark AI, Lushnikova EL. Bull Exp Biol Med. 2017 Jun;163(2):280-283. doi: 10.1007/s10517-017-3784-0
Structural Reorganization of the Vaginal Mucosa in Stress Urinary Incontinence under Conditions of Er:YAG Laser Treatment - Read Full Text.
Lapii GA, Yakovleva AY, Neimark AI. Bulletin of Experimental Biology and Medicine, 2017, 162(4):510–514.
VULVOVAGINAL ATROPHY / GENITOURINARY SYNDROME OF MENOPAUSE - RenovaLase®:
The Er:YAG vaginal laser for management of women with genitourinary syndrome of menopause (GSM) - Read Full Text.
Lin, K.-L., Chou, S.-H., Loo, Z.-X., Liu, Y.-Y., Cheng, J.-C. & Long, C.-Y., 2022. Lasers Med Sci. 2022 Jun;37(4):2203-2208. doi: 10.1007/s10103-021-03484-x
A study of the objective benefits and safety of Er-YAG laser in the treatment of genitourinary syndrome of menopause - Read Full Text.
Avul, Z. & Guven, C.M., 2023. Lasers Med Sci. 2023 Jun 4;38(1):131. doi: 10.1007/s10103-023-03798-y
Laser Treatment of Vaginal Atrophy in Post-menopause and Post-gynecological Cancer Patients - Read Full Text.
Juan F. Bojanini B., Alexandra M. Mejía C. Journal of LA&HA, Vol. 2014, No.1; pp.65-71.
Vaginal erbium laser: the second-generation thermotherapy for the genitourinary syndrome of menopause - Read Full Text.
Gambacciani M, Levancini M, Cervigni M. Climacteric 2015 Oct;18(5):757-763
Vaginal erbium laser as second-generation thermotherapy for the genitourinary syndrome of menopause: a pilot study in breast cancer survivors - Read Full Text.
Gambacciani M, Levancini M. Menopause. 2017 Mar;24(3):316-319
Treatment of Genitourinary Syndrome of Menopause with Erbium:YAG Laser: A Prospective Study of Efficacy and Safety of the Treatment for Women after Menopause of Natural Origin and Therapy-Induced Menopause in Breast Cancer Survivors - Read Full Text.
Juan F. Bojanini. J LA&HA - J Laser Health Acad 2016; 2016(1):35-40
Efficacy of erbium:YAG laser treatment compared to topical estriol treatment for symptoms of genitourinary syndrome of menopause - Read Full Text.
Gaspar A, Brandi H, Gomez V, Luque D. Lasers Surg Med. 2017 Feb;49(2):160-168. doi: 10.1002/lsm.22569
Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study - Read Full Text.
Gaspar A, Maestri S, Silva J, Brandi H, Luque D, Koron N, Vižintin Z. Lasers Surg Med. 2018 Oct;50(8):802-807. doi: 10.1002/lsm.22826
Long-term Effects of vaginal Erbium Laser in the Treatment of Genitourinary Syndrome of Menopause - Read Full Text.
Gambacciani M, Levancini M, Russo E, Vacca L, Simoncini T, Cervigni M. Climacteric. 2018;1(2):148-152. doi:10.1080/13697137.2018.1436538.
Histological findings after non-ablative Er:YAG laser therapy in women with severe vaginal atrophy - Read Full Text.
Gaspar A, Silva J, Calderon A, Di Placido V, Vizintin Z. Climacteric. 2020;23(sup1):S11-S13. doi: 10.1080/13697137.2020.1764525
Sexual function after vaginal erbium laser: the results of a large, multicentric, prospective study - Read Full Text.
Gambacciani M, Albertin E, Torelli MG, Bracco GL, Casagrande AC, Martella L, Baiocchi G, Alfieri S, Russo N, Cervigni M; Italian Vaginal Erbium Laser Academy. Climacteric. 2020;23(sup1):S24-S27. doi: 10.1080/13697137.2020.1804544
Effects of non-ablative Er:YAG laser on the skin and the vaginal wall: systematic review of the clinical and experimental literature - Read Full Text.
Hympanova L, Mackova K, El-Domyati M, et al. International Urogynecology Journal. 2020 Dec;31(12):2473-2484. DOI: 10.1007/s00192-020-04452-9
The Er:YAG vaginal laser for management of women with genitourinary syndrome of menopause (GSM) - Read Full Text.
Lin KL, Chou SH, Loo ZX, Liu YY, Cheng JC, Long CY. Lasers Med Sci. 2022 Jun;37(4):2203-2208. doi: 10.1007/s10103-021-03484-x
Short-term effect of vaginal erbium laser on the genitourinary syndrome of menopause - Read Abstract.
Gambacciani M, Levancini M. Minerva Ginecol. 2015 Apr;67(2):97-102.
VAGINAL LAXITY - IntimaLase®:
Treating Vaginal Relaxation Syndrome Using Erbium: Yttrium Aluminum Garnet Fractional Laser: A Retrospective Study - Read Full Text.
Setyaningrum, T., Tjokroprawiro, B.A., Listiawan, M.Y., Santoso, B. & Prakoeswa, C.R.S., 2022. Gynecol Minim Invasive Ther. 2022 Feb 14;11(1):23-27
Effect of laser on pelvic floor strength and sexual satisfaction in women complaining of vaginal looseness: A randomized controlled trial - Read Full Text.
Ahmed, S.M. et al. Fizjoterapia Polska, 19(2), pp.88–93.
Treating Vaginal Laxity Using Nonablative Er:YAG Laser: A Retrospective Case Series of Patients From 2.5 Years of Clinical Practice - Read Full Text.
Mitsuyuki M, Štok U, Hreljac I, Yoda K, Vižintin Z. Sex Med. 2020 Jun;8(2):265-273. doi: 10.1016/j.esxm.2020.01.001
The efficacy of erbium-doped yttrium aluminum garnet (Er:YAG) laser in the treatment of decreased sexual sensation: a randomized, placebo-controlled trial - Read Full Text.
Sathaworawong A, Manuskiatti W, Phatihattakorn C, Ungaksornpairote C, Ng JN. Lasers Med Sci. 2022 Feb;37(1):581-588. doi: 10.1007/s10103-021-03305-1
Treating Vaginal Relaxation Syndrome Using Erbium: Yttrium Aluminum Garnet Fractional Laser: A Retrospective Study - Read Full Text.
Setyaningrum T, Tjokroprawiro BA, Listiawan MY, Santoso B, Prakoeswa CRS. Gynecol Minim Invasive Ther. 2022 Feb 14;11(1):23-27. doi: 10.4103/GMIT.GMIT_141_20
Does vaginal erbium laser affect subsequent vaginal deliveries? - Read Full Text.
Gaspar, Y. Kolodchenko, J. Gaviria, I. Hreljac, Z. Vizintin. European Gynecology and Obstetrics. 2020; 2(3):193-196
Up to 3-year Follow-up of Patients with Vaginal Relaxation Syndrome Participating in Laser Vaginal Tightening - Read Full Text.
Gaviria J, Korosec B, Fernandez J, Montero G. Journal of the Laser and Health Academy, 2016(1):6-11.
Laser Vaginal Tightening (LVT) – evaluation of a novel noninvasive laser treatment for vaginal relaxation syndrome - Read Full Text.
Gaviria J, Lanz J. Journal of the Laser and Health Academy, Vol. 2012, No. 1, 46-58.
Novel Minimally Invasive VSP Er:YAG Laser Treatments in Gynecology - Read Full Text.
Vizintin Z, Rivera M, Fistonić I, Saraçoglu F, Guimares P, Gaviria J, Garcia V, Lukac M, Perhavec T, Marini L. Journal of the Laser and Health Academy, Vol. 2012, No. 1, P. 46-58.
PELVIC ORGAN PROLAPSE - ProlapLase®:
Non-ablative vaginal erbium YAG laser for the treatment of cystocele - Read Full Text.
Bizjak-Ogrinc U, Senčar S. Italian Journal of Gynaecology and Obstetrics (2017), 29(1):19-25, DOI:10.14660/2385-0868-59
Novel Minimally Invasive VSP Er:YAG Laser Treatments in Gynecology - Read Full Text.
Vizintin Z, Rivera M, Fistonić I, Saraçoglu F, Guimares P, Gaviria J, Garcia V, Lukac M, Perhavec T, Marini L. Journal of the Laser and Health Academy, Vol. 2012, No. 1, P. 46-58.
Laser Treatment of Higher Grade Cystocele - Read Full Text.
Urska Bizjak Ogrinc, Sabina Sencar. J LA&HA - J Laser Health Acad 2013; 2013(1):S22
GENITAL LESIONS:
Treatment of vulvar lichen sclerosus et atrophicus by ablative microspot erbium:YAG laser - Read Full Text.
Kofler L, Charalambous A, Kussini J, Steinert M. J Dtsch Dermatol Ges. 2023 Feb;21(2):179-180. doi: 10.1111/ddg.14955
Ablation of CIN I and VAIN II Lesions with Er:YAG Laser - Read Full Text.
Claudia Pidal and Luis Mansilla. J LA&HA - J Laser Health Acad 2019; 2019(1):CN05
Er:YAG Removal of Vulvar, Perineal, Anal and Intra-anal Condilomas - Read Full Text.
Claudia Pidal. J LA&HA - J Laser Health Acad 2019; 2019(1):CN06
Effectiveness and safety of ablative Er:YAG laser treatment for external genital warts - Read Full Text.
Bizjak Ogrinc U, Senčar S. ZdravVestn [Internet]. 31Aug.2020;89(7-8):357-64. doi: /10.6016/ZdravVestn.3050
Surgical Treatment of Vulvar HSIL: Adjuvant HPV Vaccine Reduces Recurrent Disease - Read Full Text.
Ghelardi A, Marrai R, Bogani G, Sopracordevole F, Bay P, Tonetti A, Lombardi S, Bertacca G, Joura EA. Vaccines (Basel). 2021 Jan 25;9(2):83. doi: 10.3390/vaccines9020083
OTHER:
Sutureless Laser Labiaplasty of Labia Minora - Read Full Text.
Bizjak-Ogrinc U, Senčar S. Sex Med. 2021 Oct;9(5):100406. doi: 10.1016/j.esxm.2021.100406
Characteristics of Non‐Ablative Resurfacing of Soft Tissues by Repetitive Er:YAG Laser Pulse Irradiation - Read Full Text.
Lukac M, Zorman A, Lukac N, Perhavec T, Tasic B. Lasers Surg Med. 2021 Nov;53(9):1266-1278. doi: 10.1002/lsm.23402
Variable Heat Shock Response Model for Medical Laser Procedures - Read Full Text.
Lukač M, Lozar A, Perhavec T, Bajd F. Lasers Med Sci. 2019 Aug;34(6):1147-1158. doi: 10.1007/s10103-018-02704-1
* Certain applications discussed in this scientific literature may not yet be cleared by the FDA.
Recursos adicionales: visite el sitio web de Laser and Health Academy* para obtener información adicional sobre los tratamientos médicos con láser que se pueden realizar con los equipos láser de Fotona.
