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New Option for HIV related Facial Lipoatrophy to be approved soon in the US

Posted Dec 18 2008 7:28pm
I had a call with Bioform, the makers of Radiesse yesterday. I am organizing a group of treatment activists to meet with them to discuss their patient assistance program design soon. We still do not know what the cost for HIV related work will be or what the patient assistance program will look like. I am hoping that they will be as easy to work with as Dermik (Sculptra) was.



From FACIALWASTING.ORG:



Radiesse (also called Radiense) is (calcium hydroxylapatite, (CaHA) microspheres suspended in an aqueous polysaccharide gel. Radiance, the newest product in the market, is not approved in the US as a facial filler yet but doctors are using it under an IDE study. It is manufactured by Bioform of Franksville, Wisconsin. In general, calcium hydroxylapatite has safely been used in the body for many applications including dental applications where bone build-up is needed for reconstruction and also in block form for cosmetic applications such as cheek, jaw, cranial and chin implants (hard bony areas). Calcium hydroxylapatite creates a lattice where the surrounding cells can be incorporated from ossification in bony areas to a stable scaffold in which soft tissue can grow. The calcium hydroxylapatite microspheres are suspended in a polysaccharide carrier which holds the microspheres in place until it is resorbed and the collagenation takes place. When injected in soft tissue, away from bone, fibroblasts work by building reportedly a non-scar tissue collagen type, thus creating volume in the treatment area. Its unclear where this material should be injected (dermally or sub dermally) to achieve correction of facial defects. It is being used in small quatities for wrinkle treatment and lip augmentation. It tends to be unforgiving if not applied properly. An allergy test is supposedly not needed. The especulated longevity is 2 to 5 years .



More about a study here: http://dermatology.cdlib.org/102/therapy/HIV/comite.html





INFORMATION FROM THE COMPANY:
*************************************************



RADIESSE® FACT SHEET



WHAT IS RADIESSE



Radiesse is a next-generation, long-lasting product used for soft tissue augmentation.



· Radiesse consists of calcium-based microsphere technology that naturally promotes the growth of a patient’s own collagen.



· Radiesse provides a correction that has been proven to last one year without surgery.



· Radiesse is not permanent and therefore avoids the risks associated with permanent materials.



HOW IT WORKS



Radiesse is an injectable product consisting of tiny calcium-based particles that replace volume loss and also stimulate new collagen growth for long-lasting clinical results.



· Radiesse is gently injected into the skin in very small amounts with a very fine needle. Its exclusive calcium-based microsphere technology contains tiny particles of calcium-based powder that form a scaffold around which the body produces new collagen to naturally restore the fullness and contours of the face. The tiny microspheres gradually break down into calcium and phosphate ions that are naturally absorbed by the body over time.



· Radiesse’s biocompatible composition is harmonious with the body and poses virtually no risk of an allergic reaction.



WHAT IT TREATS



Radiesse is a long-lasting soft tissue augmentation material used to correct facial wrinkles and folds, such as nasolabial folds. It also used to correct facial lipoatrophy (facial wasting) associated with HIV therapy.



WHAT SETS RADIESSE APART



Radiesse is different because it is a next-generation product that is long-lasting.



THE PROOF:



Years of rigorous clinical testing and use by physicians in more than 200,000 patients worldwide demonstrate that Radiesse is safe and effective. Further, clinical studies show that the average Radiesse treatment lasts one year.



WHO STANDS BY RADIESSE:



BioForm Medical is a privately-held medical device company that develops and commercializes injectable implants for soft tissue augmentation.



ML00179-00


********************************************

Radiesse® 12-Month HIV Facial Lipoatrophy

CLINICAL study BACKGROUNDER



Trial Background:
o A multi-site, clinical study examining the safety and efficacy of Radiesse injections for restorative treatment of HIV-associated facial lipoatrophy.

o Conducted by BioForm Medical, Inc., a privately-held medical device company specializing in injectable products for soft tissue augmentation.

o Trial conducted under an Investigational Device Exemption (IDE) granted by the FDA.

Trial Design:
o Conducted at three medical centers in the United States, including two centers in New York City and one in San Francisco.

o 100 patients with HIV-associated facial lipoatrophy were enrolled in the trial.

o All study patients received an injection of Radiesse during initial visit and were seen one month later for touch up injections as necessary.

o Additional follow up conducted at three and six months.



Key Findings:


o Patients were scored by their physician for improved appearance on the Global Aesthetic Improvement Scale (GAIS). Finding 12 months after treatment with Radiesse showed:

· 32 percent of patients’ appearance were Very Much Improved

· 52 percent of patients’ appearance were Much Improved

· 16 percent of patients’ appearance were Improved

· 0 percent of patients’ appearance was Unchanged

· 0 percent of patients’ appearance was Worse



o During the study, patients were asked how treatment with Radiesse had affected their quality of life. At 12-months follow up:

· 100 percent of patients said that treatment with Radiesse had been beneficial

· 99 percent of patients said they were more confident about their appearance after treatment with Radiesse

· 99 percent of patients said they would recommend treatment with Radiesse

· 98 percent of patients said that they felt more attractive after treatment with Radiesse

· 97percent of patients said that they felt their emotional state had improved after treatment with Radiesse



o Radiesse was safe and well tolerated, with no serious device-related adverse events reported. In all 100 patients, Radiesse was proven safe for injection.

Data Publication/ Presentation:
Study results were presented at the recent meetings of the American Society of Plastic Surgery (ASPS) and American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS).



Findings were published in a special supplement of the September 2005 issue of Plastic Surgery Journal.

Current Indications:
Radiesse is currently approved in the U.S. for treatment of the following conditions:

Oral/Maxillofacial Defects
Vocal Fold Insufficiency
Radiographic Tissue Marking
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