The Cellfina System (Ulthera Inc., a subsidiary of Merz, Inc. and a US affiliate of the global Merz Pharma Group) 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.
The minimally invasive procedure uses subcision to treat the primary structural cause of cellulite and studies have shown it improves the appearance of cellulite for results that last at least 2 years, the longest duration cleared by the FDA. In a prospective, multicenter, US clinical study, 55 patients underwent a single treatment. The system improved the appearance of cellulite in 98% of treated patients at 2 years, according to independent physician evaluators. The majority of patients (96%) reported satisfaction with their treatment at the 2-year mark, and noticeable improvement on the Global Aesthetic Improvement Scale was seen in 100% of treated patients at 2 years. Most adverse events were treatment site reactions such as bruising, soreness and hemosiderosis, which were usually mild to moderate and short in duration. No severe device-related adverse events were reported that required treatment. The Cellfina System will be available to physicians across the United States in fall 2015.
“One of the most remarkable aspects of cellulite treatment with Cellfina is the extremely high rate of patient satisfaction over time,” stated Michael Kaminer, MD, associate clinical professor of dermatology, Yale Medical School. “Our clinical data shows that patient satisfaction with the results of Cellfina treatment improved from 94% at 1 year to 96% patient satisfaction at the 2-year mark, and my work in treating my own patients continues to support these results.”
