Cellfina Cleared to Treat Cellulite for Up to Two Years


The Cellfina System from Ulthera, Inc. has received FDA clearance for the long-term improvement in the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to 2 years. Ulthera is a a wholly-owned subsidiary of Merz, Inc. The Cellfina™ System will be available to physicians across the U.S. in Fall 2015. 
Cellfina is the only FDA-cleared minimally invasive procedure clinically proven to improve the appearance of cellulite for results that last at least two years, the longest duration cleared by the FDA. The Cellfina System combines  proprietary technology with  subcision, to treat the primary structural cause of cellulite. 
Modern Aesthetics® magazine editorial board member Joel Cohen, MD recently discussed the potential clinical role for Cellfina in a recent article.
In a prospective, multicenter US clinical study, 55 patients underwent a single treatment. The Cellfina™ System improved the appearance of cellulite in 98% of treated patients at two years, according to independent physician evaluators. Importantly, 96% of patients reported satisfaction with their treatment at the two year mark, and noticeable improvement on the Global Aesthetic Improvement Scale (GAIS) was seen in 100% of treated patients at two years. Most adverse events were treatment site reactions such as bruising, soreness and hemosiderosis, which were usually mild to moderate and short in duration (lasting about 2 weeks). No severe device-related adverse events were reported that required treatment.
“In my practice, Cellfina™ has become the gold standard for treatment of cellulite on the thighs and buttocks,” stated Dr. Grant Stevens, Clinical Professor of Surgery at the University of Southern California’s Division of Plastic & Reconstructive Surgery. “I am confident that the FDA’s recent clearance of Cellfina™ for safe, effective results lasting up to two years will prove critical in helping physicians feel confident in recommending this single, minimally-invasive procedure to their patients.” A board-certified plastic surgeon in private practice at Marina Plastic Surgery in Marina Del Rey, California, Dr. Stevens, who has been voted one of the Top Plastic Surgeons in the U.S., also serves as the Director of the USC – Marina Del Rey Aesthetic Surgery Fellowship and the Co-Director of the USC Aesthetic Surgery Division.


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