According to an announcement from Merz Aesthetics, a division of Merz North America, the US Food and Drug Administration has cleared its Cellfina System to deliver results that last up to 3 years.
The Cellfina System combines a proprietary technology with a minimally invasive procedure called subcision to treat the structural cause of cellulite and help improve its appearance on the buttocks and thighs of adult females.
โThe 3-year indication shows not only the scientific rigor with which the CellfinaโขSystem was created, but also the commitment of Merz North America toward innovation and expansion of the aesthetic market through follow-on research and clinical study,โ says Jim Hartman, vice president and US Head, Merz Aesthetics and OTC, in a media release.
The FDA clearance was the result of a prospective, multicenter US clinical study of 55 patients that underwent a single treatment with the Cellfina System. The Cellfina System improved the appearance of cellulite in 98% of treated patients at three years, according to independent physician evaluators, the release explains.
Importantly, 93% of patients reported satisfaction with their treatment at the 3-year mark, and noticeable improvement on the Global Aesthetic Improvement Scale (GAIS) was seen in 100% of treated patients at 3 years. No serious device-related adverse events were reported at any time during the pivotal trial and follow-up, the release continues.
[Source(s): Merz North America, Business Wire]