CoolSculpting® Elite
System User Manual
ZELTIQ Clinical Studies
CS-UM-CM3-02-EN-D
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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 mm
2
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 mm
2
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.
Summary of Clinical Study Publications
A review of clinical publications revealed 4,792 cryolipolysis treatments during clinical studies. From
these studies, we compiled the numbers of treatments in several anatomical areas: 1,695 treatments in
the abdomen, 1,987 treatments in the flanks, 501 treatments in the back, 323 treatments in the inner
thigh, 150 treatments in the lateral thigh, 3 treatments in the anterior thigh, 119 treatments in the
submental area, and 14 treatments in the banana roll region.
Efficacy was measured by several techniques including ultrasound and caliper measurements,
circumferential measurements, 3D quantification of volume reduction, and blinded, independent review
of clinical photographs. Based on the compilation of data from these studies, the overall mean
ultrasound fat layer reduction ranged from 10.3 to 25.5% and 1.9 to 8.3 mm.
Compiled mean caliper fat layer reduction ranged from 14.7 to 23.0%. Single studies showed mean 0.9
cm circumferential reduction in the inner thigh, 2.4 cm circumferential reduction in the flanks, 6.8 cm
circumferential reduction in the abdomen, and 39.6 cm
3
volumetric reduction in the flanks.
Based on the compilation of these various studies, the overall mean ultrasound fat layer thickness
reduction was 20.6% and 3.9 mm. Compiled mean caliper fat layer reduction was 22.3%. The
independent photo review was 89.7% correct, on average.
As shown by multiple clinical studies submitted for clearance to the agency, the summary of published
data shows a similarly high safety and efficacy profile for the cryolipolysis procedure. Common
procedural side effects include erythema, bruising, and numbness, which typically resolve within one
month of treatment. Based on the literature review, 6 cases would be considered serious adverse
events. These serious adverse events include three cases of paradoxical hyperplasia in the abdomen,
one case of paradoxical hyperplasia in the abdomen, back, and flanks, one case of contour irregularity
in the abdomen, and one case of contour irregularity in the flank. For 4,792 treatments in published
studies, the incidence of serious adverse events is very low (0.13%). Given the fact that 76.8% of
treatments were to the abdomen and flanks, this incidence rate shows no clear indication of treatment
