A Multicenter Pivotal Study to Evaluate Tissue Stabilized-Guided Subcision Using the Cellfina Device for the Treatment of Cellulite With 3-Year Follow-Up

Dermatol Surg. 2017 Oct;43(10):1240-1248. doi: 10.1097/DSS.0000000000001218.


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.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Cellulite / therapy*
  • Cosmetic Techniques / instrumentation*
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Time Factors
  • Treatment Outcome
  • Vacuum