FDA Clears Merz Aesthetics' Cellfina System for Long-Term Improvement of Cellulite

The FDA has cleared the Cellfina System from Merz Aesthetics, a division of Merz North America, for the long-term improvement in the appearance of cellulite on the buttocks and thighs of adult females with no loss of benefit for up to 3 years.

Cellfina is the only FDA-cleared minimally invasive procedure clinically proven to improve the appearance of cellulite for results that last at least three years, the longest duration of any device cleared by the FDA. The Cellfina System combines  advanced, proprietary technology with subcision, to treat the structural cause of cellulite. According to market research, 78 percent of US women have cellulite that would qualify as treatable with the Cellfina System.

“The Cellfina System is quickly changing the expectations that patients and physicians have had around cellulite treatments and the results they can achieve,” stated Jim Hartman, Vice President and US Head, Merz Aesthetics and OTC. “The three-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.”

“I’ve been involved with the Cellfina System since it was first conceived as a potential treatment for cellulite. It’s been incredibly gratifying to see the treatment perform beyond the research setting,” said Dr. Michael Kaminer, Associate Clinical Professor of Dermatology, Yale Medical School. “The Cellfina System has truly been the only cellulite treatment that has delivered on its initial potential, providing women with a safe and effective treatment for their cellulite.”

The recent clearance by the FDA was a 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 percent of treated patients at three years, according to independent physician evaluators. Importantly, 93 percent of patients reported satisfaction with their treatment at the three-year mark, and noticeable improvement on the Global Aesthetic Improvement Scale (GAIS) was seen in 100 percent of treated patients at three years. No serious device-related adverse events were reported at any time during the pivotal trial and follow up.