The US Food and Drug Administration has cleared the Cellfina™ System for long-term improvement in the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to 2 years.
Cellfina is the only minimally invasive procedure cellulite procedure to hold such a distinction. The protocol involves pretreatment in which doctors meticulously mark the dimples to be treated. Local anesthesia is followed by the vacuum-assisted tissue release to break up the bands that cause cellulite. Only one treatment is needed.
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 2 years, according to independent physician evaluators. Of note, 96% of patients reported satisfaction with their treatment at the 2-year mark, and noticeable improvement on the Global Aesthetic Improvement Scale (GAIS) 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 (lasting about 2 weeks). No severe device-related adverse events were reported that required treatment, the study showed.
“In my practice, Cellfina™ has become the gold standard for treatment of cellulite on the thighs and buttocks,” says Grant Stevens, MD, clinical professor of surgery at the University of Southern California’s Division of Plastic & Reconstructive Surgery and PSP editorial advisor, in a news release. “I am confident that the FDA’s recent clearance of Cellfina™ for safe, effective results lasting up to 2 years will prove critical in helping physicians feel confident in recommending this single, minimally invasive procedure to their patients.”
Michael Kaminer, MD, an associate clinical professor of dermatology at Yale Medical School in New Haven and a partner at SkinCare Physicians of Chestnut Hill, Massachusetts, agrees. “One of the most remarkable aspects of cellulite treatment with Cellfina™ is the extremely high rate of patient satisfaction over time,” he says in a news release. “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.”