characteristics of variofill body contour...d-glucuronic acid and n-acetyl-d-glucosamine are cross...
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CHARACTER IST ICS OF VARIOF I LL BODY CONTOUR
Copyright ADODERM GmbH
CE 0297
VARIOFILL – MANUFACTURING PROCESS
A new generation of Hyaluronic Acid (HA)
Variofill® specifications below are a result of a new technology: “Monophasic Particle Technology (MPT) ” Formulation without dilution Cross linking grade: up to 80 % Cross linking agent: Divinylsulfone (DVS) Concentration: 33 mg/ml Packaging: 1x 10 ml
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The production process of Variofill®
Sodium hyaluronate (Bio-fermentation) dissolved in water
Through a new technology of an extended cross linking process with DVS a
degree of cross linking up to 80% always monitored for each batch will be
achieved.
DVS is completely washed out.
In cross linked sodium hyaluronate the hydroxyl groups of the disaccharide from
D-glucuronic acid and N-acetyl-D-glucosamine are cross linked to each other by
sulfonyl - to ethyl bridges. Sodium hyaluronate and DVS form a continuous
network and an aqueous gel during the reaction.
The 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, to facilitate the filling of the syringes with a
slightly dilution. This method is described as new “Monophasic Particle
Technology” (MPT).
A new generation of Hyaluronic Acid (HA)
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PROOF FOR DVS-FREE PRODUCTS: PROTON-NMR SPECTRA
Divinyl sulfone Non cross-linked hyaluronic acid
Shift: 6.3 – 6.9 ppm Shift: 1.6 – 4.8 ppm
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Adoderm
Varioderm 18 No peaks/echoes
from DVS
No peaks/echoes
from DVS
Varioderm
Subdermal 27
Shift: 1.5 – 5.0 ppm
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PROOF FOR DVS-FREE PRODUCTS: PROTON-NMR SPECTRA
4 times more cross linked than any other products on the market
33 mg/ml - highest concentration on the worldwide market
Excellent volume effect without overcorrection
Natural aesthetic and long lasting results
up to 18-24 months
Easy to inject without pre-testing with 16-20 G
blunt cannulas
Long filling effect merely after one treatment
To be stored at room temperature
A safe and effective product
Very strict quality controls guarantee that Variofill Body Contour® meets requirements
of European and International standards
Variofill Body Contour at a glance
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Intracutaneous irritation in rabbit (10993-10)
Sensitization in mouse (10993-10)
Acute systemic toxicity (10993-11)
In-vitro cytotoxicity (10993-5)
Genotoxicity – reverse mutation assay on Salmonella typhimurium
(10993-3)
Genotoxicity - mammalian cell gene mutation assay (10993-3)
Sub chronic Toxicity and Subcutaneous Implantation - 6 months
(10993- 6 and 11)
Variofill Body Contour passed all
Biocompatibility testing according to
international standards
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Biocompatibility – implantation test
Figure 4: Variofill gel 6 months after injection in rat hypodermis
Figure 3: Variofill gel 18 months after injection in rat hypodermis
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BIOCOMPATIBILITY – IMPLANTATION TEST
Figure 5: After 18 months, Variofill Body Contour is still in place
in the capsula and without any inflammatory reaction.
Variofill Body Contour: histology human body
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INDICATIONS
Body deformities Pectus excavatus Calf
Gluteus area
Arms shaping after weight loss
Scars after lipo-aspiration
and cellulite dimorphic surface
Leg shape in gastroctemius area
Abdominal wall gap (peritoneal skin welding)
Face contouring
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EFFICACY OF VARIOFILL BODY CONTOUR
% o
f t
rea
ted
pa
tie
nt
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VOLUME VS. DURATION
INJECTED VOLUME (ML)
DURATION (MONTHS)
OTHER FILLER
MONOPHASIC /
BIPHASIC
VARIOFILL MPT TECHNOLOGY
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Due to the high viscoelastic
properties of the Variofill and
higher concentration (33 mg/ml)
compared to others (Macrolane,
Hyacorp etc) – we recommend to
use 30-50% of Variofill less than any
other fillers for body contouring.
BENEFITS FOR THE PATIENT
• Immediate filling effect
• Less product needed to be applied – due to its high
concentration in the 10ml syringe
• Longest retention time in the soft tissues (even up to 18-24 months)
• Body contour restored for longer
• Safe and well-tested product
• Natural aesthetic look without overcorrection
• Long satisfaction of the patient from the reliable treatment
• Variofill can be used for female and male patients (restoring the
body volume in desired areas)
Before starting treatment, please inform patients about:
Composition( highly cross linked hyaluronic acid)
Characteristics (osmolarity difference)
Precautions for use (prep the skin)
Indications ( select the area and indications)
Contra-indications (skin conditions and patient sensibility)
Incompatibilities (thin and insufficient skin thickness)
Potential adverse effects (swelling, redness etc.) of Variofill®.
Keep in mind
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Before After
Variofill Body Contour injected subcutaneously in thorax 20ml by
Poland syndrome (male patient)
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VARIOFILL BODY CONTOUR TREATMENT
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Variofill Body Contour injected in the arm, 5 ml per side
(female patient) (courtesy of Dr. Fisotto, Italy) Copyright ADODERM GmbH
Left arm Right arm
Before
After
Variofill Body Contour treatment
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Off label use of Variofill in Breast augmenation
Before After
VARIOFILL injected subglandular into breast 60ml(rb) and 70ml(lb)
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Before After
VARIOFILL injected subglandular into breast 50ml(rb) and
40ml(lb)
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Before After
VARIOFILL injected subglandular into breast 50ml(rb) and
40ml(lb)
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VARIOFILL VS. MACROLANE AND HYACORP – PERFORMANCE COMPARISON
Macrolane
Hyacorp Variofill
Concentration 20 mg/ml 20 mg/ml 33mg/ml
Syringe 10 ml 10 ml 10 ml
Amount to inject to
obtain visible
effects (total
breasts)
100 ml 100 ml 60-70 ml
Buttock
augmentation
(average per side)
60-70 60-70 30-40
Duration 6 – 12 month
(claimed)
6 – 12 month
(claimed)
18-24 months
(proved)
Price *** ** ***
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VARIOFILL - CONCLUSION
• Highest concentration on the market (33 mg/ml) for the body contouring
• High degree of crosslinking degree (up to 80%)
• Excellent volume effect with less products applied
• Long duration of the filler in the skin – even up to 18-24 months
(competetive fillers: 6 months)
• Easy to inject
• 16-20 G blunt cannulas
• Secure and well-tested product
• Innovative "MPT" technology
• 8 years of full clinical data
• Made in Germany CE 0297