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A Multicenter Pivotal Study to Evaluate Tissue Stabilized-Guided Subcision Using the Cellfina Device for the
Michael S Kaminer1, William P Coleman, Robert A Weiss
1*Skincare Physicians, Chestnut Hill, Massachusetts; †Coleman Cosmetic and Dermatologic Surgery Center, Metairie, Louisiana; ‡Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland; §Connecticut Dermatology Group, Milford, Connecticut; ‖Ulthera, Inc., Mesa, Arizona.
Background:
Cellulite is a common female cosmetic concern for which no single treatment option had been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment.
Objective:
The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment.
Patients And Methods:
After completing an open-label, multicenter, pivotal study, 45 subjects were followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system. Treatment areas were photographed prior to the procedure and at multiple time points post-treatment throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was assessed based on blinded independent physician panel assessments of improvement from baseline using a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected.
Results:
The results of this trial supported Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite following TS-GS.
Conclusion:
These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.
