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July 21, 2009
Patients seeking to get facial wrinkles filled may now achieve a younger appearance without some of the discomfort of needles. BioForm Medical, the maker of popular facial filler Radiesse (calcium hydroxylapatite ) has been granted FDA approval for the process of mixing Radiesse with lidocaine, a local anesthetic, to increase patient comfort. The process was developed by dermatologist Mariano Busso, MD, who owns a private practice in South Florida and also teaches at the University of Miami.
In a clinical trial, 100 percent of patients treated with Radiesse mixed with 2 percent lidocaine found the treatment less painful than without lidocaine. Of those, 96 percent found the comfort level was significant enough to cause them to choose one treatment over another. There were no serious adverse effects in the clinical trial, and the mixture produced comparable aesthetic results to unmixed Radiesse.
BioForm plans to offer a mixing kit to physicians and is beginning an educational campaign to educate the medical community.
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