Merz Announces New Five-Year FDA Indication for Cellulite Treatment
The Cellfina® System is the first and only cellulite treatment device FDA-cleared for results that last five years with 100 percent of follow-up patients showing visible results
Merz announced today the U.S. Food and Drug Administration (FDA) has cleared Cellfina’s® new indication statement that shows the benefits of Cellfina last for five years, an increase from the previous three-year indication. Cellfina demonstrated five-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 five years of observation, making it the longest lasting cellulite treatment on the market cleared by the FDA.
The announcement about Cellfina, which consistently earns high patient satisfaction rates,1 is based on observations by an independent physician using before and after patient photographs at five years post-treatment. The results showed that after a single in-office treatment, 100 percent of follow-up patients still had noticeable improvements. Follow-up studies at one, three and five years after a single in-office treatment showed sustained improvements, solidifying Cellfina as the premier cellulite treatment.2
“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,” said Merz Americas CEO Bob Rhatigan. “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,” said board-certified Miami cosmetic dermatologist Jeremy Green, M.D. “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 five years was first presented at the 2018 American Society for Dermatologic Surgery (ASDS) annual meeting. To find Cellfina provider, visit www.cellfina.com/find-a-provider.
1 Kaminer, M.S., Robinson, D., Coleman, W.P. 3rd, Weiss, R.A., Coleman, W.P. 4th, Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite: 3 Year Update. Abstract AAD Conference 2016.
2 Kaminer MS, Robinson D, Coleman WP 3rd, et al. Multicenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite: 5 Year Update. Abstract ASDS Conference 2018.
The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits through five years of observation. Safety and effectiveness in other anatomical areas have not been established. The most common side effects reported were soreness, tenderness, and bruising. The Cellfina System is only available through a licensed physician. For full product and safety information, visit http://www.cellfina.com/IFU.
For full product and safety information, visit www.cellfina.com.
Merz North America