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product name | Radiesse |
The injectable implant is an implant RADIESSE sub-dermal and deep cohesive totally biodegradable, semi-solid, non-pyrogenic, latex-free, sterile steam. It is composed mainly of synthetic calcium hydroxylapatite, a biomaterial been used for over twenty years in orthopedics, neurosurgery, dentistry, ear-nose-throat, and ophthalmology. The calcium hydroxylapatite is in fact the main mineral component of bones and teeth. The semisolid consistency of the implant is related to the suspension of calcium hydroxylapatite in a gel carrier composed mainly of water (sterile water for injection USP) and glycerin (USP). The gel structure is determined by adding a small amount of sodium carboxymethylcellulose (USP). In vivo, the gel is dispersed to be replaced by a growth of soft tissues, whereas calcium hydroxylapatite remains at the injection site. The result is a restoration and an increase in long-term although not permanent.
The injectable implant RADIESSE is classified as Class III medical device in Annex IV MDD. The particle size of injectable implants RADIESSE 1.5 cc, 0.8 cc and 0.3 cc varies from 25-45 microns, these implants can be injected with a needle Luer 27 G or more. The utilisationd'aiguilles class less than 27 G may increase the frequency of occlusion.
Use
The implant is indicated for injection RADIESSE plastic and reconstructive surgery, including for soft tissue augmentation of the deep dermis and sub-dermal facial region.