
RADIESSE® Injectable Implant is a sterile, latex-free, non-pyrogenic, semi-solid, cohesive implant. The principal component is synthetic calcium hydroxylapatite (CaHA), suspended in a gel carrier that consists primarily of water (sterile water for injection USP), glycerin (USP/EuP) and sodium carboxymethylcellulose (USP/EuP). The gel is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection. The result is long-term yet non-permanent restoration and augmentation. RADIESSE® Injectable Implant (1.5 mL) has a calcium hydroxylapatite particle size range of 25-45 microns and should be injected with a 27G needle with a standard Luer fitting. RADIESSE® Injectable Implant is steam-sterilized using a parametric release cycle. The steam sterilization process is considered validated to a Sterility Assurance Level (SAL) of at least 10-6.
RADIESSE® Injectable Implant is intended for deep dermal and sub-dermal soft tissue augmentation. Indicated forindicated for; the treatment of nasolabial folds, the augmentation of cheeks, and hand augmentation to correct volume loss in the dorsum of the hands. RADIESSE® Injectable Implant diluted 1:2 with 0.9% sterile saline for injections is intended for the treatment of moderate and severe décolleté wrinkles
56% 25-45μm CaHA particles (w/w) 44% Gel (w/w): 36.0% sterile water for Injection, 6.6% glycerin, 1.4% sodium carboxymethylcellulose (NaCMC)
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