Injectable medical devices are products that are in direct contact with
the patient's skin and mucosa for extended periods of time.
the patient's skin and mucosa for extended periods of time.
The complete absence of systemic and, first and foremost, direct
cellular
toxicity is the essential requirement for a filler that is implanted in the skin
and remains there for 8 months (on average).
toxicity is the essential requirement for a filler that is implanted in the skin
and remains there for 8 months (on average).
For this reason in particular, in order to exclude even the lowest of
cytotoxic
effects, increasingly sensitive cytotoxicity assays are needed - which
means performing in vitro tests using immortalised human keratinocytes as cell line.
effects, increasingly sensitive cytotoxicity assays are needed - which
means performing in vitro tests using immortalised human keratinocytes as cell line.
Cytotoxicity can be assessed with the MTT test, which relies on
mitochondrial
activity. The test, originally developed by Mosman in 1983, is simple,
ccurate and yields reproducible results (Mosman, 1983). The MTT test is
based on the principle that, in most viable cells, mitochondrial activity is
constant, so an increase or decrease in the number of cells is directly
proportional to mitochondrial activity. Viable cells convert MTT tetrazolium
salts into formazan crystals, which can be solubilised in dimethyl sulphoxide
(DMSO) for homogeneous spectrophotometric measurement.
Therefore any change in the number of viable cells can be detected by
measuring the optical density of formazan at 570 nm.
activity. The test, originally developed by Mosman in 1983, is simple,
ccurate and yields reproducible results (Mosman, 1983). The MTT test is
based on the principle that, in most viable cells, mitochondrial activity is
constant, so an increase or decrease in the number of cells is directly
proportional to mitochondrial activity. Viable cells convert MTT tetrazolium
salts into formazan crystals, which can be solubilised in dimethyl sulphoxide
(DMSO) for homogeneous spectrophotometric measurement.
Therefore any change in the number of viable cells can be detected by
measuring the optical density of formazan at 570 nm.
NEAUVIA STIMULATE Hydrogel 26 mg of HA with 1 % hydroxyapatite
has shown complete absence of cytotoxicity at various concentrations,
even ones higher than the normal concentration used for clinical purposes.
has shown complete absence of cytotoxicity at various concentrations,
even ones higher than the normal concentration used for clinical purposes.
NEAUVIA STIMULATE is a "hybrid" filler, new, safe and reversible,
which concentrates in a single product both the tissue filling functions
of a filler and the collagen production of particle fillers, which already
have successfully been on the market for years. The amount of collagen
produced by NEAUVIA STIMULATE is comparable to particle fillers,
without having the problem of being irreversibile. NEAUVIA STIMULATE
is recommended for interventions on hands, cheeks, nasoslabial
and jaw area, and the aesthetic corrections last approximately 12 months.
which concentrates in a single product both the tissue filling functions
of a filler and the collagen production of particle fillers, which already
have successfully been on the market for years. The amount of collagen
produced by NEAUVIA STIMULATE is comparable to particle fillers,
without having the problem of being irreversibile. NEAUVIA STIMULATE
is recommended for interventions on hands, cheeks, nasoslabial
and jaw area, and the aesthetic corrections last approximately 12 months.
Prime Journal
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