Format

Send to

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

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

Author information

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.

Abstract

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.

PMID:
28661995
DOI:
10.1097/DSS.0000000000001218
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Wolters Kluwer
Loading ...
Support Center