Derma Veil is a lyophilized low viscosity, non-toxic, bioabsorbable and biodegradable tissue reconstructive material with the following characteristics: – Injectable single use medical device incorporated as a hydrophilic matrix.
Its active principle is composed of glycolic acid (GA) bound to the polymeric column of polylactic acid [PURASORB Poly (L-lactide)] both of which are homogeneously dispersed throughout and their rate of release is controlled by diffusion, prolonging a sustained repairing action through the slow dissolution of the compound.
– Immunologically inactive, biocompatible and absorbable and is degraded by hydrolysis.
The degradation begins first by water diffusion in the material, initially at the more amorphous zones, followed by hydrolysis, material fragmentation and finally, a more extensive hydrolysis along with phagocytosis, diffusion and metabolization.
Elimination occurs primarily through the respiratory tract.
Each box of Derma Veil contains 2 vials and an Instruction for Use leaflet.
The vials are made of transparent borosilicate glass, sealed with a siliconized halobutyl stopper secured by an aluminum ring with a “flip off” plastic cap.
The vial has 10 mL capacity and contains 236.
14 mg of a lyophilized, sterile, pyrogen free, crystalline white powder of asymmetric micro-particles (40 to 60 m) made of: – POLYLACTIC ACID a biocompatible, biodegradable synthetic polymer for medical applications, [PURASORB Poly (L-lactide)] – GLYCOLIC ACID a biocompatible, biodegradable, high purity hydroxyacetic acid monomer for medical applications, – CARBOXY METHYL CELLULOSE SODIUM (USP), – MANNITOL (USP), – POLYSORBATE 80 (NF), INTENDED USE: Derma Veil is applied by subdermal injection to treat moderate to severe facial fat loss (lipoatrophy) caused by degenerative changes that occur due to illness or advanced age.
Its application triggers a foreign body reaction promoting a glucosaline biosynthesis that increases cellular interactions favoring the production of new collagen.
The process generates histological changes that provide greater fullness to the cutaneous tegument.
These functions provide reconstruction to collapsed areas while diminishing skin depressions such as wrinkles, creases and minor scars.
– The treatment requires a minimum of two sessions separated by 3 weeks (20 days).
– Derma Veil is activated prior to use by adding preferably 8mL of Physiological Saline Solution (0.
91% w/v of NaCl, about 300 mOsm) or 8mL of Sterile Water for Injection (pyrogen and preservative free) Once activated, the formula becomes a suspension of relative viscosity.
– Derma Veil should be injected using a sterilized 26G (0.
45mm x 13mm) needle.
STORAGE: Keep Derma Veil in dry storage, away from humidity and light, at a temperature between 15 C (59 F) and 30 C (86 F).
Refrigeration is not necessary.