Radiesse approval expands in European Union to treat wrinkles in décolleté area

Radiesse, composed of calcium hydroxylapatite, was previously authorized to address facial wrinkles, folds, and hand volume loss. The recent extension of its approval, endorsed by a pivotal study, allows Radiesse to treat wrinkles in the décolleté region within the European Union, as announced by Merz Aesthetics in a press release. This product is a sterile, non-pyrogenic, semi-solid, cohesive implant consisting of 30% synthetic calcium hydroxylapatite and 70% carrier gel. Radiesse obtained CE certification in the EU in 2003 and was FDA-approved for treating facial wrinkles and folds in 2006, followed by approval for hand volume loss in 2015.

Radiesse has been approved in the European Union to treat wrinkles in the décolleté area.
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 wrinkles at 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.