varioderm brochure

VARIODERM® is...• a new generation of highly concentrated and cross-linked hyaluronic acid filler

• for various indications in the dermis and subcutis• convincing with long-lasting clinical results

more than just a promise!

T H E A R T O F F A C I A L R E J U V E N A T I O N

0297 MADE IN GERMANY

MESOLIFT FINE LINE LIPS & MEDIUM

12.8 mg/mlnot cross linkedhyaluronic acid

superficial wrinklesfaceneck

decolleteback of hands

3 months*

30G

2 x 1.0 ml

superficial dermis

6 mg/mlhigh cross linkedhyaluronic acid

superficial to medium wrinklesperioral lines

general touch up

3-6 months*

30G

2 x 1.0 ml

superficial to middle dermis


medium wrinklesespecially lip augmentation

and lip contour

6-12 months*

27G

1 x 1.0 ml

middle dermis to deep dermis

ConcentrationHyaluronic acid

Content

Indications

Estimated duration

Needle size

Packaging

Skin level

Skin Moisturisation Wrinkle Treatment

Injection technique based on the indications:*Estimated duration depending on several factors

PRECAUTIONS

VARIODERM® is intended to be used exclusively by a medical professional trained in injection techniques of soft tissue fillers. The information contained in this brochure is not complete and describes the product only in a general way. For more information, please refer to the packaging insert.

Before performing the treatment, inform your patients about the composition, characteristics, precautions for use, indications and contra-indications, incompatibilities and potential adverseeffects of the implant as specified in the packaging insert.


medium wrinklesand lip contour

6-12 months*

27G

2 x 1.0 ml

middle dermis to deep dermis


deep wrinklescontour of the face

and volume creation

12-14 months*

27G

2 x 1.0 ml

deep dermis / hypodermis


very deep wrinklesespecially

contour of the faceand volume creation

14-18 months*

27G

2 x 1.0 ml

hypodermis and epiperiostal

ConcentrationHyaluronic acidContent

Indications

Estimated duration

Needle size

Packaging

Skin level

BASIC PLUS SUBDERMAL

Voluminization

PACKAGING

Each box contains:• two pre-filled 1,0 ml syringes with Varioderm• one pre-filled 1,0 ml syringe with Varioderm

Lips & Medium• a packaging insert• a set of batch numbered labels for traceability• a set of needles

Keep the product at room temperature between +2°C and +25°C.

linear retrotracing, multiple point and fan techniqueas patient skin type, type of Injection, quantity, severity of the defect

PRODUCT CHARACTERISTICS

Concentration 12.8 mg/mlHyaluronic acid Content high cross linked hyaluronic acid

Indications medium wrinklesespecially lip augmentationand lip contour

Estimated duration 6-12 months*

Needle size 27G

Packaging 1 x 1.0 ml

Skin level middle dermis to deep dermis

Injection-Technique Retro tracing, Serial points, Fan-Techniques or a combination of all above

Storage between +2°C and +25°C

Shelf life 2 years

cheek wrinkles

cheeks

cheeks

nasolabial wrinkles

chin wrinkles

chin

oral commissuresbitterness wrinkles

lip augmentation / perioral lineslip contour / vermillion border

periorbital lines

perioral lines

decollete


Concentration 12.8 mg/mlHyaluronic acid Content not cross linked hyaluronic acid

Indications superficial wrinklesface, neck, decolleteback of hands

Estimated duration 3 months*

Needle size 30G


Skin level superficial dermis

Injection technique Serial puncture technique, Retrograde linear threading technique, Fan technique


Shelf life 2 years

neck

Skin Moisturwrinkle treatm


Concentration 12 mg/mlHyaluronic acid Content high cross linked hyaluronic acid

Indications medium wrinklesand lip contour


Needle size 27G


Skin level middle dermis to deep dermis



Shelf life 2 years

oral commissuresbitterness wrinkles

chin wrinkles

nasolabial wrinkles

lip augmentation / perioral lines

cheek wrinkles

lip contour / vermillion border



Indications superficial to medium wrinklesperioral linesgeneral touch up


Needle size 30G


Skin level superficial to middle dermis



Shelf life 2 years

urisation and ment products

CLINICAL STUDY – VARIODERM FINE LINE,

VARIODERM BASIC, VARIODERM PLUS, VARIODERM SUBDERMAL

Courtesy of Doctor Aref Alsoufi, Bad Homburg, GermanyPublished in Plastische Chirurgie, 04/2008

82 patients (13 males, 69 females)Age: 26 - 68 years

VARIODERM FINE LINE

VARIODERM BASIC

VARIODERM PLUS

VARIODERM SUBDERMAL

Indications

15% perioral

2% chin

5% glabella

11% cheeks

29% marionettes wrinkles

22% lips

48% nasogenian folds

1% crowfeet

2% cheekbones

DURATION IN MONTHS



Indications deep wrinklescontour of the faceand volume creation


Needle size 27G


Skin level deep dermis / hypodermis



Shelf life 2 years

0 3 6 9 12 15 months

augmentation of cheekbones(malar augmentation)

chin augmentation

cheek contours

nasolabial folds

cheek augmentation

Volumizing psubcutaneou

bitterness folds

oral commissures

augmentation of cheekbones(malar augmentation)

CLINICAL STUDY – VARIODERM®SubdermalCourtesy of doctor Michael Weidmann, Augsburg – GermanyPublished in European Dermatology, Vol. 1 - 2009, (65-68)

39 patients (5 males, 34 females) Age: 28 - 69 years

SAFETY – VARIODERM®SubdermalIn case of, reactions were transient and patient complained light redness and swelling for 1 hour to 3 days.

Reactions

0% strong

7% medium

37% light

56% no reaction

Indications

5% chin

15% bitterness wrinkles

26% cheekbones

31% nasogenian folds

5% scars

44% cheeks

oral commissures

bitterness folds

nasolabial folds

cheek contours

cheek augmentation

nose bridge augmentation

nose



Indications very deep wrinklesespecially contour of the faceand volume creation


Needle size 27G


Skin level hypodermis andepiperiostal

Injection-Technique Retro tracing, Serial points, Fan-technique or a combination of all above


Shelf life 2 years

products for ous injection

chin augmentation

IMPLANTATIONTESTS

Experimental and Biocompatibility Studiesdemonstrated the long duration and safety of Varioderm products. Histological studiesshow 7 months duration of VARIODERM®Subdermal in rats skin.

Figure 1 VARIODERM® Subdermal: 7 months after in-jection in rat hypodermis (magnification x10).Meshlike connective tissue (reddish) includesmany small encapsulated gel particles (stainedin blue). No inflammatory reaction is observed(no giant multinucleated cells, no macrophages).

Comparison of durability with other HA-fillers to VARIODERM®Comparative kinetic study demonstrates theadvantage of VARIODERM®: up to twice morevolume is observed at the same time after onlyone injection.

Extended cross linking process

Months

VARIODERM®

OTHER

Safety and performance

100%

80%

60%

40%

20%

0% Volu

me

Hyaluronic Acid(106 Daltons)

Solution between 6-27mg/ml

HIGHEST CROSS LINKED HYALURONIC ACID WORLDWIDE

The previous manufacturing methods generate hyaluronic acids of various qualities: more orless diluted monophasic solutions or suspensionof particles. However, the traditional processesfor obtaining hyaluronic acid do not achieve the optimal durability after injection in the softtissue. This is why ADODERM GmbH has chosento develop a new generation of hyaluronic acidwith a longer durability in the soft tissue.

Manufactured according to inovative methods of: “Monophasic Particle Technology” (MPT)

VARIODERM® is a soft-tissue filler made of cross-linked and particulated hyaluronic acid.

PurificationHyaluronic acid contained in VARIODERM® products is obtained by bio-fermentation. After extended cross linking process the obtained gel is purified.

Particulisation and HomogenisationThe highly concentrated and cross linked hyaluronic acid, which has a significantly higher viscosity compared to the initial mixture, is subsequently formed into particles and stabilized, without need of any dilution. This method is described as the inovative"Monophasic Particle Technology” (MPT).

Sterilisation and Final PackagingAfter filling, glass syringes are sterilised andpackaged into blister containers. Then, syringes,packaging insert, traceability labels and needlesare enclosed into the box.

Test and Final ReleaseBefore release, all tests (sterilisation, bacterialendotoxin, pH-value, etc.) are carried out according to European Pharmacopoeia and international standards.

Figure 1

Figure 2

ParticularisationHomogenisation

0 5 10 15

PHYSICAL PROPERTIES OF VARIODERM FILLERS

HA dermal fillers available on the market differin properties such as elasticity, viscosity, andextrusion force. These physical properties deter-mine their final clinical performance. Elasticity,viscosity and extrusion force are directly propor-tional to concentration, degree of cross-linkingand particle size of the HA dermal fillers.A better knowledge of the physical properties of dermal fillers can therefore be very useful forphysicians in choosing the appropriate HA der-mal filler for facial contouring and/or a specificindication. The elasticity and viscosity of HAdermal fillers are directly proportional to theirvolumizing and lifting capabilities of soft tissue.The physical properties of a hydrogel (e.g. HAdermal fillers) are described using a variety ofrheological terms, like elastic modulus and vis-cous modulus. The elastic modulus G´ (G prime)is proportional to the extent of the elastic component of the hydrogel and the viscousmodulus G´´ (G double prime) is proportional to the extent of the viscous component of thehydrogel.

Figure 3 shows the rheological properties ofVARIODERM fillers. VARIODERM fillers withgreater elastic modulus G´ and viscous modulusG´´ have a better filling effect and a longer duration time in the soft tissue.

The extrusion force of HA dermal fillers is clini-cally relevant, because the physician must injectthe HA dermal filler through a thin needle intosoft tissue. The extrusion force of prefilledsyringes can be determined by means of atesting device according to DIN EN ISO 7886-1(Annex G: Determination of forces required tooperate the plunger). The measurements of theextrusion force were performed with a 27Gneedle (Figure 4).

VARIODERM fillers have significantly bettervisco-elastic properties and lower extrusion forces than several on the market available HAdermal fillers. This is mainly due to the innovati-ve monophasic particle technology (MPT) usedin the production process for the VARIODERMfillers. The optimized physical properties of theVARIODERM fillers allow for better clinicalresults.

Viscous modulus G’’ [Pa]

extrusion in mm

Ela

sti

c m

od

ulu

s G

’ [P

a]

forc

e i

n N

10

10

15

5

10

20 30

100 1000

Subdermal

Plus

Basic

Subdermal

Plus

Basic

Lips&Medium

Lips&Medium

Mesolift

Fineline

10

100

1000

10000

Figure 3

Figure 4

FREQUENTLY ASKED QUESTIONS

How long do the results last?VARIODERM® persists in the dermis for at least 3 to 18 months. The high degree of crosslinkingsupports a slower resorption of VARIODERM® inthe tissue. The durability of VARIODERM® in theskin varies according to skin type, age and theway of life of the patient as well as treated areaand injection technique. It can be necessary torenew the treatment partially in order to opti-mize the results and durability of the correction.

Are there any precaution measures to be undertaken?• After the injection, it is recommended to

apply ice or a cooling device on the treated areas in order to decrease the transitory inflammation due to injection.

• Make-up should be avoided during the first twelve hours following the injection.

• The client must also avoid saunas, steam bath, UV rays and exposure to cold during 10 days following the injection.

• In the event of prolonged exposure to the sun, a sun block should be applied to the treated areas.

Are there contra-indications?VARIODERM® should not be used on pregnant women or breast feeding. It should not be injected in a patient presenting an auto-immunedisease, antecedents of allergy or over-sensi-tiveness to the hyaluronic acid, or a immuno-therapeutic treatment. VARIODERM® should notbe injected into inflammatory and/or infectiousskin (acne, herpes, impetigo…), skin prone todevelop hypertrophic scars. It should not beused in conjunction with any laser treatment,chemical peeling or dermabrasion. A prior con-sultation with the patient will enable you toknow the medical history, especially previousaesthetic treatments (like injections) and todetermine if VARIODERM® is suitable to this individual case. For more information pleaserefer to the packaging insert of VARIODERM®.

Are there undesirable effects?As with all skin fillers swelling and/or redness, with or without associated pain, may occur afterthe injection. These generally disappear within afew hours, days or in some cases within a week. Some rare cases of necrosis, abscess, granulomaor of over-sensitivity have been described in thescientific literature after injections of hyaluronicacid. Continuation of these reactions or appea-rance of any other side effects must be reportedto the practitioner by the patient as soon as possible in order to resolve it by appropriatetreatment. The distributor should also be in-formed about this incident. Before treatment,please inform the patient about the potentialside effects related to this injectable implant.

VARIODERM® – TREATMENT

VARIODERM® products are made of non-animalorigin hyaluronic acid. They are medical devicesdesigned to be injected by a doctor experiencedspecifically in the techniques of filling facialwrinkles by injection in the dermis and sub-cutaneous tissue.

The area to be treated must be properly cleanedwith disinfectant solution before the injection.The treatment is easy and quick. Thanks to itslow extrusieon force and the use of the thin pro-vided needles, the injections are precise, simpleand almost painless. Depending on the sensiti-vity of the patient, an anaesthesia cream may beappropriate. On certain sensitive areas such aslips, it is recommended to give a local nerve-blocking anaesthesia.

Using enclosed thin needles (between 27-30G)VARIODERM® products can be injected slowly inthe mid or deep dermis or subcutaneous tissueby linear withdrawal technique (tunnel techni-que), by serial puncture- or fan-technique or bya combination of these techniques. The treatedzone must be slightly massaged after injectionin order to spread well the implant.

The quantity of VARIODERM® products to beused depends on the depression to fill and thedesired effect.

With VARIODERM® products, optimal volumizingeffect is easy to obtain, with less quantity to beinjected. No overcorrection is needed. Pleaseread the packing insert for further information.

REFERENCES

1- Klein AW, Elson ML, The history of substances for soft tissue augmentation, Dermatol Surg, 2000, 26: 1096-1105.

2- Baumann L, Dermal fillers, J Cosmetic Dermatol, 2005, 3: 249-250.

3- Coleman S and the Plastic Surgery Educational Foundation DATACommittee, Cross-linked hyaluronic acid fillers, Plast Reconstr Surg,2006, 117(2), 661-665.

4- Tezel A, Fredrickson GH, The science of hyaluronic acid dermalfillers, Journal of Cosmetic and Laser Therapy, 2008, 10: 35-42.

5- Larsen NE, Pollak CT, Reiner K, Leshchiner E, Balazs EA, Hylan gel biomaterial: dermal und immunologic compatibility, J BiomedMater Res, 1993, 27(9), 1129-1134.

6- Klein AW, Techniques for soft tissue augmentation, Am J ClinDermatol, 2006, 7: 107-120.

7- Duranti F, Salti G, Bovani B, Calandra M, Rosati ML, Injectable hyaluronic acid gel for soft tissue augmentation: A clinical and histological study; Dermatol Surg 1998; 12:1317-25.

8- Friedman PM, Mafong EA, Kauvar ANB, Geronemus RG, Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation, Dermatol Surg, 2002, 28: 491-494.

9- DeLorenzi, C, Weinberg M, Solish N, Swift A, A multicenter study of the efficacy and safety of subcutaneous nonanimal stabilized hyaluronic acid in aesthetic facial contouring: Interim report,Dermatol Surg, 2006, 32: 205-211.

10- Brody HJ, Use of hyaluronidase in the treatment of granulomatoushyaluronic acid reaction or unwanted hyaluronic acid misplacement,Dermatol Surg, 2005, 31: 893-897.

11- Glaich SA, Cohen JL, Goldberg LH, Injection necrosis of the glabella: protocol for prevention and treatment after use of dermal fillers, Dermatol Surg, 2006, 32(2): 285-290.

12- Weidmann MJ, Varioderm – A new generation of hyaluronic acid,European Dermatology, 2008, 3: 50-53.

13- Weidmann MJ, New Hyaluronic acid filler for sub-dermal and long-lasting volume restoration of the face, European Dermatology,2009, 1: 65-68.

14- Alsoufi A, New and innovative developments in hyaluronic acid fillers for lip enhancement and contouring, European Dermatology,2010, 5: 50-53.

15- Alsoufi A, Hyaluronic Acid Fillers: A retrospective analysis of 108 cases of patients receiving hyaluronic acid filler for long-lastingvolume restoration on the face, Prime, 2011, 1(5): 62-64.

16- Mieles ER, Hand Rejuvenation with Hyaluronic Acid, Prime, 2012,2(2), 76-77.

17- Bingöl AÖ, Dogan A, Physical Properties of Hyaluronic Acid Fillersand their Relevance for Clinical Performance, Magazin für ästhetischeChirurgie, 2012, 2, 6-12.

ADODERM GmbH • Elisabeth-Selbert-Str. 5 • D-40764 Langenfeld • Germanyt +49 (0) 2173 / 101 91 80 • f +49 (0) 2173 / 101 91 82 • [email protected]

www.adoderm.com

Your Distributor

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varioderm brochure

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27g2 x

30g2 x

27g1 x

mlmiddle dermis

packaging insert

varioderm lips medium

various indications

mlskin level middle