Biomedical Engineering Reference
In-Depth Information
Vacuum suction within the applicator was used to ensure tight
contact and optimal positioning of the skin and area to be
treated, between the two cooling plates (Fig. 12.1). This design
also decreases blood fl ow within the skin fold, which allows for
more rapid and effi cient cooling of the skin. The clinician then
selected a cooling intensity factor (CIF), a value representing
the rate of heat fl ux in or out of the tissue. After 60 minutes of
cooling at a set CIF, the treatment was complete and the device
was removed, leaving a fi rm area of fat that becomes soft over
several minutes after removing the applicator.
The latest generation of device requires no input from the
treating physician. Early clinical studies demonstrated that
compared with 30 minutes, 60 minutes of cooling fat led to
far better results. To date, multiple clinical studies have
demonstrated the effi cacy and safety of cryolipolysis for fat
layer reduction in humans. In a pivotal study, 32 patients
with localized fat accumulation of the fl anks (“love handles”)
demonstrated clinical improvement as measured by digital
photography, physician assessment, and subject satisfaction.
In this study, 10 patients underwent ultrasonography of their
treated area, which showed an average reduction of 22.4%
in fat layer thickness (Fig. 12.2) (8). In a subsequent study,
50 patients underwent treatment of one fl ank followed by
photography of the treated and untreated sides. Based on
these photographs, three blinded physicians were able to dif-
ferentiate between pre- and posttreatment sites in 82% of
patients (9). These studies resulted in FDA clearance in the
summer of 2010.
(
B
)
(
A
)
Figure 12.1
(
A
) The treatment applicator for cryolipolysis applied to the abdomen; notice the suction of fat into the applicator. (
B
) The fat is a solid wedge after
removing the applicator after a 60-minute cycle; this clears within 10 minutes.
(
A
)
(
B
)
Figure 12.2
Clinical images before (
A
) and results 3 months after (
B
) a clinical study with the large applicator. Patients are told that they may expect a 25% reduc-
tion in fat from a single cycle.
Source
: Courtesy of Zeltiq Aesthetics, Inc.
