Radiesse approval expands in European Union to treat wrinkles in décolleté area
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Key takeaways:
- Comprised of calcium hydroxylapatite, Radiesse was previously approved to treat facial wrinkles, facial folds and volume loss in hands.
- This expanded approval is supported by a pivotal study.
Radiesse has been approved in the European Union to treat wrinkles in the décolleté area, Merz Aesthetics announced in a press release.
Radiesse is a sterile, non-pyrogenic, semi-solid, cohesive implant comprised of 30% synthetic calcium hydroxylapatite and 70% carrier gel. In 2003, Radiesse achieved CE certification in the EU and was also approved by the FDA for the treatment of facial wrinkles and folds in 2006 and for volume loss in the hands in 2015.
Radiesse’s expanded indication to the décolleté area in the EU reflects the widespread patient demand as the rate of nonsurgical procedures worldwide increased 171.8% between 2018 and 2022, according to the press release.
“Despite being one of the most visible areas of our bodies, the décolleté area is often overlooked when it comes to aesthetics,” Samantha Kerr, PhD, chief scientific officer of Merz Aesthetics, said in the release. "Radiesse presents a unique solution to improving décolleté wrinkles and provides our customers and their patients a nonsurgical, effective option to address aging décolleté skin.”
The approval is supported by the positive results from a pivotal, prospective, randomized study in which Radiesse was evaluated for 1 year in 117 patients with moderate to severe wrinkles in the décolleté area.
Results showed that 73.5% of treated patients achieved at least a 1-point improvement on the Merz Aesthetics Scale for décolleté wrinklesat rest at week 16 following the last treatment.
Reference:
- Radiesse. https://merzaesthetics.com.sg/radiesse/. Accessed Jan. 30, 2024.
- Merz North America announces FDA approval of Radiesse for use in the hands. https://www.biospace.com/article/releases/merz-north-america-announces-fda-approval-of-radiesse-for-use-in-the-hands-/. Updated Jun. 5, 2015. Accessed Jan. 30, 2024.
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