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.
“The 3-year indication shows not only the scientific rigor with which the Cellfina™System 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,” 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]