ZELTIQ Clinical Studies
CoolSculpting® Elite
System User Manual
56
CS-UM-CM3-02-EN-D
site specificity. The clinical publications indicate that cryolipolysis is a safe and effective non-surgical
procedure for subcutaneous fat reduction.
Summary of Clinical Study Publications for the
Submental and Submandibular Areas
Six clinical publications reported safety and effectiveness of 228 cryolipolysis treatments in 102 patients
to include 89 patients with a Body Mass Index (BMI) of up to 46.2 and 27 patients treated in the
submental and submandibular areas.
Literature review of cryolipolysis indicates that clinicians are currently treating below the entire
mandible, including both the submental and submandibular areas, in order to achieve best aesthetic
outcome. See Table 20, which summarizes the applicator placement methods tabulated from the six
publications. Two applicator placement approaches are identified: single cycle placed in the center
submental area, as well as two cycles covering the bilateral submandibular area, with a 20 – 30%
overlap in the center submental area. demonstrates a typical two-cycle placement method treating
submental and submandibular areas.
Reported safety included common procedural side effects such as erythema, bruising, numbness,
edema, blanching, tingling, increased sensitivity, itching, pigmentation changes, tenderness, and
hoarseness, typically resolving within one month of treatment. It is believed that these side effects are
not specifically quantified and reported in all publications because they are expected, self-resolving,
and considered minor; thus, reports of erythema, bruising, pain, and transient numbness are likely
under-reported. From the publications that reported a total of 228 treatment cycles, the most common
side effects at 1-week post-treatment were numbness (105 reports), tingling (24), edema (9), and
erythema (3 reports).
Several techniques measured effectiveness, techniques including ultrasound measurement, caliper
measurement, Magnetic Resonance Imaging (MRI), three-dimensional (3D) quantification of volume
reduction, patient satisfaction, and blinded, independent review of clinical photographs. The mean
ultrasound measurement of fat layer reduction was 2.4 mm with a range from 2.0 to 2.8 mm. The mean
caliper measurement of fat layer reduction was 3.17 mm (around 33%) with a range from 2.3 to 4.0
mm. The single study using MRI imaging showed mean reduction of 1.78 mm or 17% subcutaneous fat
layer reduction. The 3D imaging showed a mean calculated reduction of 8.5 mL fat volume, and
calculated reduction in submental laxity by 2.25 mm. Three-dimensional volumetric measurement
showed a fat reduction of 4.82 cm
3
. Blinded, independent photo review was conducted in several
studies with correct identification of baseline photographs ranging from 60% to 91%, averaging 77%.
Patient satisfaction ranged from 80% to 93%, averaging 85%.
There were no device or procedure-related serious adverse events related to treatment of the
submental and submandibular areas in the six publications.
