In November, Syneron Medical Ltd. announced that it received a new FDA 510(k) clearance of its minimally invasive, fractional radiofrequency (RF) microneedling device Profound.
The new indication is for using the device with the 75o SubQ handpiece and cartridge to improve the appearance of cellulite.
“Profound is the first and most effective single minimally invasive treatment for cellulite that provides a meaningful improvement,” Macrene Alexiades, M.D., PhD, tells Cosmetic Surgery Times.
Dr. Alexiades, who is director and president of the Dermatology & Laser Surgery Center of New York, was an investigator of a recent multi-center clinical study of Profound, which examined and analyzed the dimples and/or undulation irregularities in the thighs of 50 women with Fitzpatrick skin types I – III.
“We demonstrated a significant improvement in cellulite on the thigh after a single treatment,” Dr. Alexiades reports. “In total, 94% and 93% of people whose thighs were treated with Profound showed marked improvement by blinded evaluation in the appearance of their cellulite and skin at 3 and 6 month follow-up, respectively, after a single treatment.”
Moreover, at 6 months after a single treatment, “94% and 100% of people treated reported improvement in their cellulite and skin texture, respectively,” Dr. Alexiades says.
Dr. Alexiades says other skin-surface modalities take as many as 7 to 14 treatment sessions to notice a modest improvement in cellulite. Likewise, invasive procedures like liposuction “carry side effects and risks of complications,” she says.
Profound’s 25º dermal handpiece and cartridge are already used for percutaneous treatment of facial wrinkles, “yet can also help with skin texture on the body,” Dr. Alexiades says.
Syneron Candela plans to release Profound for the treatment of cellulite in 2017.
“Cellulite is an aesthetic quality that people continually report feeling uncomfortable with, particularly on their thighs,” says Dr. Alexiades, an associate clinical professor at Yale University School of Medicine. “We view the recent data for Profound for the treatment of cellulite as a real success for people apprehensive about invasive procedures and who are looking for a relatively painless and effective single treatment option to help reduce the appearance of cellulite.”