The US Food and Drug Administration (FDA) has cleared a new indication statement that shows the benefits of the Cellfina System lasts for 5 years, an increase from the previous 3-year indication, Merz announces.
Cellfina demonstrated 5-year improvement in the appearance of cellulite on the buttocks and thighs of adult females. The FDA clearance is supported by clinical data demonstrating treatment benefits through 5 years of observation, making it the longest-lasting cellulite treatment on the market cleared by the FDA, according to Merz in a news release.
The announcement about Cellfina is based on observations by an independent physician using before-and-after patient photographs at 5 years post-treatment. The results showed that after a single in-office treatment, 100% of follow-up patients still had noticeable improvements. Follow-up studies at 1, 3 and 5 years after a single in-office treatment showed sustained improvements, the release suggests.
“This formal recognition from the FDA is a significant milestone for Cellfina customers, their patients and Merz. Research shows women oftentimes feel defeated by their battle with cellulite, and we want to make sure our customers have an effective cellulite treatment option,” Merz Americas CEO Bob Rhatigan says.
“Cellfina is the only cellulite treatment FDA-cleared for visible results that last five years. We are proud of this new indication, and it is a true testament to Cellfina’s efficacy and our commitment to bring customers the latest innovations in medical aesthetics.”
Cellfina combines highly advanced, proprietary technology with a well-established procedure called subcision to treat the structural cause of cellulite. The primary structural cause of cellulite is the connective bands woven throughout fat in the thighs and buttocks. These tight bands pull down the skin, creating the puckering seen on the surface of the skin. It’s this precise and innovative technology that specifically targets the real cause of cellulite.
“Cellfina is the benchmark and continues raising the bar for any other cellulite treatments, with both longevity of results and effectiveness,” board-certified Miami cosmetic dermatologist Jeremy Green, MD, states, the release continues.
“Cellulite is an emotionally charged, medical condition that affects 85 percent of women worldwide. While the data has clearly shown that Cellfina works, and does so for five years, the FDA clearance indicates to consumers that they can, and should, expect to see proven, long-lasting results after treatment with Cellfina.”
The study data for 5 years was first presented at the 2018 American Society for Dermatologic Surgery (ASDS) annual meeting.
[Source: Merz USA]