Evolence Dermal Filler


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Dr. Patrick Treacy presents the dermal filler Evolence to FACE Conference London in 2007

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  • Both are recommended for:
    Nasolabial folds
    Marionette lines
    Volume restoration
    Evolence Breeze has shorter fibers size, is less viscous suits papilary dermis and can be injected with a 27G needle. It can be injected more superficially than Evolence should be injected mid/deep dermis
    Natural results & immediate and long term patient satisfaction: Data on file, 160 patients, post MKT surveillance program and follow up study on 30 patients included on EU study, that were injected with both Evolence and Restylane
  • Pre clinical evidence of longevity of Evolence, compared to other collagens
    Not only the product is visible after 24 months, but also that the volume injected has been reduced by only xx% after 6 monts, 12 and 24 months
  • MFWS: Modified Fitzpatrick Wrinkle Score
    EVOLENCE 30 est la première version d’EVOLENCE à avoir existé, à 30mg/ml de collagène. Aujourd’hui tous les produits ont une concentration de 35 mg/ml
    Need p value and standard deviation bars
    Missing baseline value
  • Rabbit skin
  • The results with EVOLENCE implant are consistent with other dermal fillers, which do not require pretreatment skin testing. Rate of allergy with bovine collagen is around 3%, Restylane and human collagen: 0,
    More than 150.000 people received OSSIX : No allergic reaction
  • Evolence Dermal Filler

    1. 1. 04/14/1404/14/14 11 Before & After Pictures Case Studies
    2. 2. 04/14/1404/14/14 22
    3. 3. 04/14/1404/14/14 33
    4. 4. 04/14/1404/14/14 44 Nasolabial Folds:Nasolabial Folds: Before & Immediately After InjectionBefore & Immediately After Injection Before After
    5. 5. 04/14/1404/14/14 55 What Is the Ideal Filler?What Is the Ideal Filler? Medical Point of ViewMedical Point of View  Natural,Natural, predictable resultspredictable results  Minimal downtime/Minimal downtime/ immediate effectsimmediate effects  Cost effectiveCost effective  SafeSafe  Long-lasting, butLong-lasting, but also biodegradablealso biodegradable Consumer Point of ViewConsumer Point of View  Natural lookNatural look  Instant gratificationInstant gratification —lunch time—lunch time procedure;procedure; no/minimalno/minimal downtimedowntime  SafeSafe  Long-lasting butLong-lasting but
    6. 6. 04/14/1404/14/14 66 True Beauty, All Year LongTrue Beauty, All Year Long EVOLENCEEVOLENCE  True results – the benefit of collagenTrue results – the benefit of collagen  True duration - Glymatrix™ technologyTrue duration - Glymatrix™ technology provides results that last at least 12provides results that last at least 12 monthsmonths  True science – Johnson & JohnsonTrue science – Johnson & Johnson leadershipleadership
    7. 7. 04/14/1404/14/14 77  Indicated for the correction of soft tissueIndicated for the correction of soft tissue contour deficiencies or deformitiescontour deficiencies or deformities  Pre filled syringes of 1ml and 0,5mlPre filled syringes of 1ml and 0,5ml  Storage at Room temperatureStorage at Room temperature  EVOLENCE – 27G needleEVOLENCE – 27G needle  EVOLENCE Breeze – 30G needleEVOLENCE Breeze – 30G needle EVOLENCE & BreezeEVOLENCE & Breeze 1,2 : Data on file, Colbar lifescience
    8. 8. 04/14/1404/14/14 88 Why collagen?Why collagen? Collagen characteristics:Collagen characteristics:  Collagen is the key structural biomaterialCollagen is the key structural biomaterial  Collagen makes 70-80% of the dermisCollagen makes 70-80% of the dermis11  Collagen is non-hydrophillicCollagen is non-hydrophillic Collagen benefits:Collagen benefits:  Predictable & natural resultsPredictable & natural results  No need for touch up or over fillNo need for touch up or over fill  Less edema, erythema, bruisingLess edema, erythema, bruising  Ideal for modeling and sculpturingIdeal for modeling and sculpturing
    9. 9. 04/14/1404/14/14 99 Why Porcine source?Why Porcine source?  Provide the benefits of collagenProvide the benefits of collagen  Extremely low immunogenicityExtremely low immunogenicity  Closest to human collagenClosest to human collagen  Well documented as safe biomaterial inWell documented as safe biomaterial in medical devices and proceduresmedical devices and procedures
    10. 10. 04/14/1404/14/14 1010 Why Glymatrix technology?Why Glymatrix technology?  True duration – at least 12 monthsTrue duration – at least 12 months  Natural materials only – Collagen andNatural materials only – Collagen and sugarsugar  Same process as the natural glycation inSame process as the natural glycation in the dermisthe dermis  No toxicicity (different to BDDE andNo toxicicity (different to BDDE and
    11. 11. 04/14/1404/14/14 1111 EVOLENCEEVOLENCE DurationDuration  Pre clinical study - Intracutaneous injections of EVOLENCE 30 intoPre clinical study - Intracutaneous injections of EVOLENCE 30 into the dermisthe dermis of the ears of 14 New Zealand rabbits in comparison with Zyplastof the ears of 14 New Zealand rabbits in comparison with Zyplast®® and Zydermand Zyderm®® . Histopathological examination indicated that. Histopathological examination indicated that EVOLENCE is safe with no evidence of degradation at 1, 6, 12, andEVOLENCE is safe with no evidence of degradation at 1, 6, 12, and 24 months.24 months. EVOLENCEEVOLENCE ZyplastZyplast®® ZydermZyderm®® 1 Month1 Month 6 Months6 Months 1212 MonthsMonths 2424 MonthsMonths
    12. 12. 04/14/1404/14/14 1212N= 12 PT – Immediately after second treatment. Baseline – 2 weeks after second treatment. Clinical StudiesClinical Studies EVOLENCE DurationEVOLENCE Duration Randomized controlled study, intra individual comparison Accepted for publication in Plastic & Reconstructive Surgery,2007
    13. 13. 04/14/1404/14/14 1313 EVOLENCE BiocompatibilityEVOLENCE Biocompatibility Indications ofIndications of suitability andsuitability and biocompatibility:biocompatibility:  ResemblingResembling staining patternstaining pattern  One continuousOne continuous main bulkmain bulk  Integration ofIntegration of fibroblastsfibroblasts  No signs ofNo signs of Pre clinical study - EVOLENCE implant after 1 month (H&E)
    14. 14. 04/14/1404/14/14 1414 VascularizatiVascularizati onon FibroblastFibroblast ss EVOLENCE biocompatibilityEVOLENCE biocompatibility Enlarged Histology ImageEnlarged Histology Image Preclinical Study
    15. 15. 04/14/1404/14/14 1515 Hyaluronic Acid histologyHyaluronic Acid histology Different histologicalDifferent histological structure:structure:  FenestratedFenestrated appearanceappearance  Clear interfaceClear interface boundaryboundary  no fibroblastsno fibroblasts within HAwithin HA Preclinical study - Hyaluronic acid dermal implant after 1 month (H&E)
    16. 16. 04/14/1404/14/14 1616 EVOLENCE SafetyEVOLENCE Safety  More than 700 patients injected withMore than 700 patients injected with Evolence in clinical studies and post clinicalEvolence in clinical studies and post clinical surveillance and followed up (for up to 2surveillance and followed up (for up to 2 years) : ZERO allergic reactionyears) : ZERO allergic reaction  More than 30.000 syringes injectedMore than 30.000 syringes injected worldwide : ZERO related hypersensitivityworldwide : ZERO related hypersensitivity reportedreported  More than 150.000 people received OSSIXMore than 150.000 people received OSSIX ( dental implant with collagen and glymatrix( dental implant with collagen and glymatrix technology): No allergic reactiontechnology): No allergic reaction
    17. 17. 04/14/1404/14/14 1717 EVOLENCE SafetyEVOLENCE Safety  Recently finished study in the US:Recently finished study in the US: Two sequential skin testsTwo sequential skin tests 530 subjects injected530 subjects injected No positive hypersensitivity response duringNo positive hypersensitivity response during the study periodthe study period No antibody elevationNo antibody elevation  These results indicate thatThese results indicate that a skin testa skin test before treatment with EVOLENCEbefore treatment with EVOLENCE implant is not warrantedimplant is not warranted
    18. 18. 04/14/1404/14/14 1818 1.DeLustro, F., S.T. Smith, J. Sundsmo, G. Salem, S. Kincaid, and L. Ellingsworth. Reaction to injectable collagen: results in animal models and clinical use. Plast. Reconstr. Surg. 79:581-592, 1987. 2.1case out of 438 patients. Ref.: Lowe, N.J., C.A. Maxwell, P.L. Lowe, et al. Hyaluronic acid skin fillers: adverse reactions and skin testing. J. Am. Acad. Dermatol. 45:930-3, 2001. 3.2cases out of 271 patients. Ref.: Lowe, N.J. Temporary dermal fillers- European experiences. In Textbook of Facial Rejuvanation, chapter 16, pgs. 177-188. 4.Evolence Skin Test Study USA. 0 patients out of 530 patients. Upperbound rate of 0.58%. Data on file. ColBar LifeScience 1 2,32,3 4 Hypersensitivity Rate in Dermal Fillers 0.00% 1.00% 2.00% 3.00% 4.00% 5.00% Skin test rate 3.00% 0.00% 0.00% 0.00% Rate to treatment 1.30% 0.23% 0.74% 0.58% Zyderm Hylaform Restylane Evolence1 2,3 2,3 4
    19. 19. 04/14/1404/14/14 1919