Multicenter pivotal study of vacuum-assisted precise tissue release for the treatment of cellulite.
BACKGROUND
Cellulite refers to the dimpled appearance of skin occurring where the dermis is tethered by subcutaneous fibrous septa arranged perpendicularly to the skin surface.


OBJECTIVE
To demonstrate the safety and efficacy of a new system for vacuum-assisted precise tissue release for the treatment of cellulite.


METHODS
Adult women with moderate to severe cellulite (N = 55) underwent a single treatment. Post-treatment assessments were performed after 3 and 14 days; 1, 3, and 6 months; and at 1 year. Outcome measures included blinded assessments of subject photographs, a validated Cellulite Severity Scale (CSS), and the Global Aesthetic Improvement Scale. Subject satisfaction and pain ratings were also recorded.


RESULTS
The mean baseline CSS score of 3.4 decreased to 1.3 at 3 months (p < .0001) and 1.4 at 1 year (p < .0001), with 47 subjects (93%) having ≥1-point improvements. Subject satisfaction was 85% at 3 months and 94% at 1 year. Transient treatment-related adverse events were mild in severity.


CONCLUSIONS
This study demonstrates the safety, efficacy, and subject satisfaction with vacuum-assisted precise tissue release in the treatment of cellulite. There was no reduction in treatment benefits for up to 1 year. These results supported the Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite.
*Skincare Physicians, Chestnut Hill, Massachusetts; †Coleman Center for Cosmetic and Dermatologic Surgery, Metairie, Louisiana; ‡Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland; §Apothekon, Inc., Woodbury, Minnesota.
Michael S
MS
Kaminer
William P
WP
Coleman
Robert A
RA
Weiss
Deanne M
DM
Robinson
W Patrick
WP
Coleman
Carl
C
Hornfeldt
D000273:Adipose Tissue / Q000601:surgery*; D000328:Adult; D002081:Buttocks; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015187:Lipectomy / Q000295:instrumentation*; D008875:Middle Aged; D009765:Obesity / Q000473:pathology / Q000601:surgery*; D017060:Patient Satisfaction; D013848:Thigh; D016896:Treatment Outcome