Multicenter pivotal study of vacuum-assisted precise tissue release for the treatment of cellulite.

Abstract

Cellulite refers to the dimpled appearance of skin occurring where the dermis is tethered by subcutaneous fibrous septa arranged perpendicularly to the skin surface. To demonstrate the safety and efficacy of a new system for vacuum-assisted precise tissue release for the treatment of cellulite. 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. 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. 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.