venus viva adatto white paper may 2016

ClinicalExperiencewithaNovelNanoFractionalRadiofrequencyBasedAestheticDeviceUsedfortheImprovementofScarsMauriceA.Adatto,M.D.,SkinpulseDermatology,Laser&BeautyCenter,Geneva,SwitzerlandBackgroundRegardless of the etiology, scars have always beennotoriously challenging to treatwith truly effectivetherapeuticoptionsfewandfarbetween.Dependingonthelocationofthescarandtheindividualpatient,scars can be a source of considerable physical aswellaspsychologicaldistressandcanbethecauseofsignificant anxiety and depression in the affectedpatient. This can often lead to a loss of self-esteemand a stigmatization of the patient frequentlyresultinginadiminishedqualityoflife(1,2).Beyondthe psychological impact, scars can also beassociated with severe itching, tenderness, pain,sleep disturbances, and can cause the disruption ofdaily activities, begging the need formore effectivetreatment solutions for this common aestheticindication.Scar formation is part of the natural physiologichealingprocessfollowinganinjurytotheskinwheretypically, collagen fibers will cross-link and form apronounced alignment in a single direction insteadofhavingarandombasketweaveformationasseenin normal, non-scarred dermal tissue. Theappropriate treatment of scar tissue depends onseveraldifferentfactorsincludingthedepthandsizeof the scar, its location, as well as the age, gender,ethnicity and genetics of the individual patient.Several different types of scars and scarmorphologies exist including keloidal scars,contracture scars, hypertrophic scars, and acnescars. Acne scars can be categorized into atrophic,hypertrophic or keloidal type scarring. Oftendominated by the presence of fibrous tissue andfibroticbandsrunningthroughoutthedermisinthehistopathology, atrophic acne scars are furthersubdivided into ice pick scars, rolling scars, andboxcarscars,whicharedefinedashavinglessthana2mmdiameterdefectattheskin’ssurface,agreaterthan 4-5mm diameter defect at the skin’s surface,anda1-4mmdiameterdefectat theskin’s surface,anda0.1-0.5mmdepth,respectively.

The choiceof scar treatment is often guidedby thetype, age, and location of the scar lesion. Over theyears, several different treatment modalities havebeenusedandtriedaloneandincombinationfortheimprovementofscars.Theseincludesurgery,punchbiopsy/excision, intralesional corticosteroidinjections, subcision, cryotherapy, silicone sheeting,fillerinjections,electrodessication,aswellastheuseof various scar minimizing creams and gels.Resurfacing techniques have also been triedincluding chemical peeling, dermabrasion andmicrodermabrasion (1-3). Continued researchhowever has led to the development andimplementation of novel energy-based technologiesthat are used to resurface the target skin regionleading to a smoother more homogenousappearance of the skin. Both ablative andnonablative laser technologies have beensuccessfully employed for scar therapy however,these modalities are often limited by their sideeffects including post-inflammatoryhyperpigmentation (PIH) as well as prolongedhealing times, particularly true for ablative lasers.Largely viewed as a paradigm shift in skinrejuvenation therapy, the dawn of fractionaltechnology has been shown to be very effective inthis regard, achieving excellent cosmetic outcomeswhile keeping potential adverse events anddowntime to a minimum (4-16), particularly whencompared to non-fractional energy-basedmodalities. Bridging the gap between ablative andnonablativemodalities,fractionaltechnologycreatespredeterminedsymmetriccolumnsofmicrothermalzones (MTZ) surrounded by healthy unaffectedtissue,resultinginmuchquickerhealingtimes.An ideal treatmentcanbecharacterizedassafeandeffectivewithminimaltonodiscomfortperceivedbythe patient as well as little to no downtime. Oneleading technology that has been shown to fulfillthese criteria is fractional radiofrequency (RF)-

based devices, which have a proven efficacy andsafety for the treatment of numerous aestheticthornsincludingrhytids,skinlaxity,skintextureandsmoothening as well as the aesthetic improvementof scars with very little downtime. Fractional RFtechnology has been proven to effectively andefficientlydeliverheatenergydeepintothetargeteddermis, resulting in fibroblast stimulation, dermalremodeling, neocollagenesis, and elastogenesis,while only causing very minimal disruption of theepidermis, leading to excellent treatment outcomeswith minimal downtime. In this paper, we presentour clinical experiences using a novelNanofractional™ radiofrequency-based aestheticdeviceforthetreatmentandimprovementofscars.MaterialsandMethodsDeviceDescriptionVenusViva™ (VenusConcept,Toronto,Canada) isafully customizable, noninvasive treatment solutionfor many of the demanded indications commonlyseenintheaestheticpracticetoday.Havingreceivedan official nod from Health Canada and FDAclearance for facial remodeling and resurfacing, theVenus Viva device (Figure 1) is engineered tosuccessfully address amyriad of common aestheticindications that fall under the umbrella of skinrejuvenation including skin laxity, wrinkles, finelines,rhytids,skintexture,acneandtraumaticscars,dyschromia, rosacea, striae distensae, and enlargedpores.Figure1.VenusVivadevice

Proven tobe safe forallFitzpatrickSkinTypes, theVenusVivasystememploysNanoFractional™RFandinnovative proprietary SmartScan™ technology thatenable precision control over the heated zonedensity and unique pattern generation duringtreatment, resulting inhomogenous treatmentsandreproducible clinical outcomes. These twotechnologies are delivered to the targeted skin viathe Viva™ applicator, ideal for the treatment oflarger surface areas. The ergonomic applicatorhouses 160 pins/tipwith 62mJ/pin, and a smallerpin footprint (150x20 microns), treatment withwhichresultsinminimaldowntimeduetothemicrowound created. Energy is delivered to each micro-pin individually maximizing patient comfort andensuring that the tissue is treated uniformly. Thepatentedtiptechnologywithadepthofpenetrationof up to 500 microns allows for varying energydensities during treatment, which enables bothmanually controlled ablation of the epidermis andcoagulation of the targeted dermis resulting in aprecisionresurfacingoftheskin.MethodsPatients presenting with Fitzpatrick Skin Typesranging fromII-IIIandvarious typesof scar lesionslocated in different anatomic regions underwentmultiple treatments with the Venus Viva aestheticdeviceforthepurposeofimprovingtheappearanceoftheirscars.Inourpatientcohort,anytypeofscarwas considered for Venus Viva therapy includingsurgical and post-traumatic scars, and both fresherythematous colored scars aswell asolder, longerstanding,hypopigmentedand/oratrophicscars.Thepatients included in thisobservationwere followedup at each subsequent treatment session, and pre-andpost-treatmentclinicalphotographsweretakenat baseline and at each follow up visit, and weremade available for comparison at the end of thetreatmentperiod.Treatmentsafetywasassessedbythe frequency and severity of adverse eventsreported throughout the duration of the treatmentperiod.Allofthepatientsprovidedwritteninformedconsentpriortotheinitiationof therapy,andnotedtheir satisfaction from the treatment procedure atthepredeterminedfollowupvisits.Just prior to performing the Venus Viva scartreatment,anymoisturizercreamandmake-upwas

thoroughly removed from the target skin, followedby ameticulous disinfection of the area using 70%alcohol and then degreasing with a mixture ofacetone20%inwater.The typicalparametersusedduring the scar treatmentprocedurewerebetween250 to 270 V, and between 6 to 10 msec pulseduration.According toourprotocol, the thicker theindividual patient’s skin and individual scar, thelonger the pulse duration and higher fluence wasused.Foreachofthescarsaddressed,amaximumof3 passes were performed perpendicular to thesurface of the skin, with a slight angle in betweeneach pass to avoid pulse stacking. After thecompletion of each treatment, a calmingmoisturizingcreamwasamplyappliedtothetreatedskin region, such as Cicalfate Baume B5 (La RochePosay).ResultsOver50femaleandmaleCaucasianpatientsrangingin age from 20 to 75 years and Fitzpatrick SkinTypes from II to III received treatment with theVenusVivaaestheticdevice for the improvement inthe appearance of their scars. The treated scarslesions were of mild to moderate severity, andincluded post-surgical and post-traumatic scars aswell as post-acne scarring located on differentanatomic areas such as the face, forehead, lowereyelid, cheek, nose, chin, upper lip, chest, shoulder,breasts, abdomen, forearm, hand, and knee. Ourpatients underwent anywhere from 2 to 8treatments with the device depending on theindividual clinical presentation as well as thelocation of the scars addressed, until a satisfactoryoutcome could be achieved. It was found thatregardlessofthescartype,ageofthescar,aswellasanatomic location, Venus Viva treatments couldsignificantly improve the scar tissue in all of ourpatients. Results showed that all of the scarsachieved a marked improvement in theirappearance, some as soon as post two treatmentssessions with the device (Figures 2a and 2b). Postsurgical scars also showed significant improvementincolor,texture,andoverallappearance(Figures3aand 3b, and Figures 4a and 4b). Only a mild buttransient erythema was observed in the targetedskin immediately following each treatment session,and none of the patients experienced any adverseevents.Allofthepatientsreportedahightolerability

from treatment, and the vast majority of patientswerecontentwiththeimprovementsachievedintheappearanceoftheirscars.Figure 2a. Baseline image depicting a scar on theupperlip6monthspostMohssurgery

Figure2b.Imagetakenpost2treatmentsessionswiththeVenusVivadevice

Figure 3a. PostMohs surgery scar on dorsum of thenose

Figure 3b. Post 4 treatments with the Venus Vivadevice

Figure 4a. Baseline image of multiple surgical scarsovertheabdomen

Figure 4b. Post 5 treatment sessions with the VenusVivadevice

DiscussionIn this observation that included over 50 patientswithvarious typesof scarring indifferentanatomicregions, we used the Venus Viva system, a novelNanofractional radiofrequency device for thetreatmentandcosmeticimprovementofscarlesions.Allofthetreatedscarsinourpatientsdemonstratedsignificant improvement in their appearance, aswitnessed in the comparative before and afterimages.Afteronlyafewtreatments,thetextureandcolorofthescartissueappearedmorehomogenousin respect to the adjacent healthy looking non-scarred skin. The treated scars also appearedmoreflush to the skin, further enhancing the cosmeticresult.Noneofthepatientsexperiencedanyadverseevents and patients were very satisfied with thetreatmentandoutcomesachieved.Several different treatment modalities andtechniques are currently being used for theimprovement in the appearance of scar lesionsranging from various surgical techniques andenergy-basedaestheticdevicestoamyriadoftopicaltherapies. Energy-based aesthetic systems inparticular used for the cosmetic improvement ofscars are more popular than ever in aestheticmedicine today due to the significant impact theycan have on scar tissue. Fractional radiofrequency-based devices have proven to be particularlysuccessful for this indication due to their favorableaesthetic outcomes coupled with an excellent sideeffectprofile(1,4-7,11,14).

Theimpactofradiofrequencytechnologyintheskinis based on dermal heating and the subsequenttherapeutic fallout of the induced tissueinflammation.Duringtreatment, theradiofrequencyenergy will heat the targeted skin and initiate aninflammatoryresponse,leadingtoadenaturationofcollagen and the stimulation of fibroblasts togenerate new collagen and elastic fiber formation.Fractionated bipolar radiofrequency technologyeffectively delivers thermal energy deep in to thedermis, resulting in significant dermal remodeling,neocollagenesis, and elastogenesis, while onlycausing very minimal disruption of the epidermis.The exemplary NanoFractional radiofrequencytechnology found on the Venus Viva device proveditsgreatutilityinthecosmetictreatmentofscarsofdifferent etiologies, as witnessed in this patientcohort. This novelmode of RF energy delivery andsubsequent tissue inflammation and repair cascadehas been demonstrated time and again to achieveexcellentskinrejuvenationoutcomesforamyriadofcosmeticindicationsincludingwrinklesandrhytids,dyspigmentation,striaedistensae,rosacea,aswellasscars. As similarly found in previous studies usingfractionalbipolarradiofrequencyforscartreatment,thepositive results achieved in this small cohort ofpatients further supports theuseofNanoFractionalradiofrequency technology for the treatment andimprovement in mild to moderate scar lesions ofvaryingetiologies.References1.SimmonsBJ,GriffithRD,Falto-AizpuruaLA,NouriK. Use of radiofrequency in cosmetic dermatology:focus on nonablative treatment of acne scars. ClinCosmetInvestigDermatol.2014Dec12;7:335-9.2.LanoueJ,GoldenbergG.Acnescarring:areviewofcosmetictherapies.Cutis.2015May;95(5):276-81.3. Peterson JD, Palm MD, Kiripolsky MG, Guiha IC,Goldman MP. Evaluation of the effect of fractionallaser with radiofrequency and fractionatedradiofrequency on the improvement of acne scars.DermatolSurg.2011Sep;37(9):1260-7.4. Verner I. Clinical evaluation of the efficacy andsafety of fractional bipolar radiofrequency for the

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