FDA clears Cellfina System for cellulite treatment lasting 2 years

Ulthera announced that the FDA has cleared the Cellfina System for treatment of cellulite on the buttocks and thighs with results lasting at least 2 years.

The Cellfina System combines proprietary technology with subcision to treat the primary structural cause of cellulite, according to a press release.

“One of the most remarkable aspects of cellulite treatment with Cellfina is the extremely high rate of patient satisfaction over time,” Michael Kaminer, MD, associate clinical professor of dermatology, Yale Medical School, stated in the 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.”

Fifty-five patients underwent treatment in a prospective, multicenter U.S. clinical trial, according to the release. Independent physician evaluators reported 98% of patients treated with Cellfina had improved appearance of cellulite at 2 years, and 96% of patients reported treatment satisfaction at 2 years. There was improvement in Global Aesthetic Improvement Scale in 100% of patients at 2 years, according to the release.

Bruising, soreness and hemosiderosis were adverse events reported at treatment site, which were mild-to-moderate and lasted about 2 weeks, according the release. No severe device-related adverse events were reported.

“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,” Grant Stevens, MD, clinical professor of surgery in the division of plastic & reconstructive surgery at the University of Southern California, said in the release.

“As the newest addition to Merz‘s growing aesthetic portfolio, Cellfina has quickly established a strong reputation among patients and physicians alike as an effective, minimally-invasive way to treat cellulite with long lasting results,” said Patrick Urban, vice president and head of the Ulthera Business Unit at Merz North America, said in the release.

Ulthera is an affiliate of Merz North America. The Cellfina System will be available to physicians in the U.S. in the fall, according to the release.

Reference: www.merzusa.com