Multicenter Pivotal Study of Vacuum-Assisted Precise Tissue Release for the Treatment of Cellulite

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

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