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Hyaluronic acid filler

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Presentation on theme: "Hyaluronic acid filler"— Presentation transcript:

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2 Hyaluronic acid filler
Product description mesofiller is a sterile, injectable and resorbable medical device based on cross-linked hyaluronic acid to be used as a temporary filler for the correction of aesthetic concerns such as wrinkles or depressions. t allows firming the tissues and filling intradermal spaces and intercellular matrix.

3 Concentrations mesofiller soft 20 mg/ml (2%) mesofiller medium
Hyaluronic acid filler Concentrations mesofiller soft 20 mg/ml (2%) mesofiller medium 25 mg/ml (2,5%) fine lines and wrinkles in the periocular or perilabial area. deep wrinkles, nasolabial fold, cheeks and lips.

4 Packaging contents 1 information pamphlet 1 blister
Hyaluronic acid filler Packaging contents 1 information pamphlet 1 blister 1 * 1ml prefilled, graduated, disposable and sterile glass syringe 2 sterile 27G½ needles 2 traceability adhesive labels

5 Top quality crosslinking technique
Hyaluronic acid filler Top quality crosslinking technique Crosslinking agent: BDDE The crosslinking balance is essential for maintaining both the duration and the biocompatibility of the HA filler. There are mainly two different crosslinking agents: DVS (divinyl sulfone) and BDDE (butanediol diglycidyl ether). BDDE is considered as a higher end product that allows an easier and more universal filling. Crosslinking agent residues: < 50 ppb (=0.05 ppm) Probably one of the purest HA in the market obtained thanks to an advanced purification techniques. Standard fillers use to carry around 50 ppm residues (1’000 times more)

6 Technical data One-phase
Hyaluronic acid filler Technical data One-phase Origin: biotechnogical (non-animal; produced via bacterial fermentation) Molecular weight: MDa (raw material) Dynamic viscosity: mesofiller soft: 170 Pa-s mesofiller medium: 250 Pa-s pH: Endotoxins: < 0.5 EU/ml (LAL test- kinetic chromogenic method) Steam sterilised

7 Regulatory context & quality guarantees
Hyaluronic acid filler Regulatory context & quality guarantees MEDICAL DEVICE CE Produced according to the ISO 9001, ISO and GMP standard (Good Manufacturing Practice). Biocompatibility studies performed according to the ISO guide lines.

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