ZELTIQ CoolSculpting System, Руководство пользователя

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ZELTIQ Clinical Studies System Overview
12 BRZ-101-TUM-EN2-L
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively affect the
appearance of visible fat bulges in the upper arm area with treatment at -11°C for 35 minutes.
Summary of Submental Area Study
A prior study (ZA14-002), approved by the Food and Drug Administration (FDA) under IDE G140083, reported
the efficacy of cryolipolysis for non-invasive reduction of submental fat. Subsequently, a retrospective study
was carried out in which standardized, masked, photographic images from the original ZELTIQ-sponsored
clinical study were evaluated quantitatively to determine the efficacy of the CoolSculpting treatment in
affecting the appearance of lax tissue in the submental area.
This retrospective study started with the ZA14-002 per-protocol population (n=58) for analysis, excluded one
subject due to excessive hair in the submental region, and used the remaining fifty-seven (57) subjects for
analysis. Lateral photographic views of the face taken at baseline and at the 12-week post-final treatment visit
were included in the analysis. Each photograph was cropped and masked prior to evaluation. A board-certified
plastic surgeon identified the following anatomical points on each photograph: the lateral canthus, the
anterior-most point where the nostril meets the columella, and the point where the chin meets the neck
(submental crease). AutoCAD software was used to apply lines to each photograph, and areas in the submental
region were measured. A responder analysis was performed with the criteria being ≥ 20 mm2 decrease in area
as measured on both the right lateral and left lateral views of the region.
A second analysis was performed in which reviewers compared the results from the responder analysis against
results from the independent physician review panel of photos, which had been conducted in the previous
study. This second analysis indicated that 77.2% (44/57) of subjects exhibited a
≥ 20 mm2 area reduction in the
submental and neck tissue. Of those 44 subjects, 42 (95.5%) were correctly identified by the physician panel as
having a visible response.