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Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and
bones. For wrinkle filling, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into
the wrinkle. The effects of this material last approximately 18 months. Calcium hyroxylapatite injections have been
used as a "wrinkle-remover" since 2006, calcium hyroxylapatite injections have also been used in other applications.
Radiesse BioForm Medical, Inc. Approval Date: December 22, 2006
Radiesse is an injectable calcium hydroxylapatite implant in the form of a gel. Radiesse works by temporarily adding
volume to facial tissue and restoring a smoother appearance to the face. Radiesse is intended for restoration and/or
correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. It is injected by a
doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds
volume to the skin and can give the appearance of a smoother surface. Radiesse will help smooth moderate to severe
facial wrinkles and folds. The smoothing effect lasts up to six months. Side effects of Radiesse include: bruising, and
FDA approves Radiesse for treating facial lipoatrophy
On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant
to restore or correct signs of facial lipidatrophy, or fat loss, in people with human immunodeficiency virus (HIV).
Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite suspended in a gel
carrier, is a medical device. It is already approved for use as a tissue marker, for treatment of vocal fold insufficiency,
and to correct certain dental defects. The most common adverse side effects reported were temporary edema
(swelling), ecchymosis (bruising), erythema (reddening) and/or pain at the injection site. The calcium hydroxylapatite
(CaHA) particles in Radiesse can be seen in X-rays and CT Scans. Radiesse is a product of BioForm Medical Inc., of
Coaptite® BioForm Medical, Inc. Date of Notice of Approval November 10, 2005
COAPTITE® is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to
intrinsic sphincteric deficiency (ISD) in adult females. Coaptite® is an injectable, sterile, non-pyrogenic implant
composed of spherical particles of calcium hydroxylapatite (CaHA) (75 - 125 microns in diameter), suspended in an
aqueous based gel carrier. The gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection,
and glycerin. The gel carrier suspends the CaHA particles, allowing their delivery through injection needles, and is
dissipated in vivo, while the CaHA particles remain at the injection sites to provide soft tissue augmentation.
Pore-Si ApaTech Limited 510(K) Premarket Notification January 15, 2004
Pore-Si is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not
intrinsic to the stability of the bony structure. Pore-Si is indicated to be packed gently into bony voids or gaps of the
skeletal system, i.e. extremities, spine and pelvis. These defects may be surgically created osseous defect or osseous
created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone
during the healing process. Pore-Si is phase-pure hydroxylapatite osteoconductive bone void filler, comprising a
single-phase calcium hydroxylapatite scaffold.
Calcium Hydroxylapatite Implant 510(k) Premarket Notification Submission June 25,2003
Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oraVmaxillofacial defects
including: Periodontal Defccts Ridge Augmentation Extraction Sites and Craniofacial Augmentation Cystic Defects.
Calcium Hydroxylapatite ImpIant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium
hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and
oral/maxillofacial defects, Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in B pasty gel of
glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles.