FDA approves Radiesse dermal filler for hand augmentation-Merz North America
Merz North America has announced that Radiesse has received FDA approval for hand augmentation to correct volume loss in the dorsum of the hands. Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to 1 year.
In a randomized, controlled US trial, blinded evaluators reported that Radiesse improved the appearance of both hands in 75% of treated patients at 3 months. Importantly, 98% of treated patients also reported improvement in the appearance of their hands at 3 months. Improved aesthetic outcomes as measured on the Global Aesthetic Improvement Scale (GAIS) after initial and repeat treatments correlating with clinical improvement were demonstrated in this study, with all primary and secondary endpoints being met.
Most adverse events were injection site reactions such as swelling, redness, pain and bruising, which were usually mild to moderate, short in duration (lasting about 1 week), and required no treatment. No severe device-related adverse events were reported that required treatment.
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