Biomedical Engineering Reference
In-Depth Information
Twenty patients with thigh and buttock cellulite were ran-
domized to receive 12 biweekly VelaSmooth treatments in a
split-leg fashion. Of the 16 patients who completed the study,
31.25% experienced bruising at some point during the study.
At 4 and 8 weeks after the last treatment, 50% (at both time
points) of subjects had over 25% improvement in the appear-
ance of cellulite in the treated leg, as graded by the investi-
gator's quartile-based scale. At 4 and 8 weeks after the last
treatment, 50% and 68.75%, respectively, of subjects had
over 25% improvement in the appearance of cellulite in the
treated leg, as graded by an independent investigator-evalu-
ated, quartile-based scale. At 8 weeks of follow-up, 31.25% of
patients had greater than 51% improvement in the appear-
ance of cellulite in the treated leg as graded by the indepen-
dent investigator (26).
Similar, split-anatomic controlled studies with the 20-W RF
and 20-W IR VelaSmooth have continued to show improve-
ment in the appearance of cellulite as rated by investigator-
based (29,30) and subject-based (29) grading scales. Many
authors have recommended monthly maintenance treatments
to help sustain the clinical improvements (24,29).
RF and the other bipolar RF, which is FDA-cleared for the
treatment of wrinkles and rhytides. As compared with bipo-
lar RF, unipolar RF is able to affect deeper structures (up to
15-20 mm) (31-33). The Accent XL UniPolar treatment
head emits electromagnetic radiation, and heat production
is generated through high-frequency (40.68 MHz) oscilla-
tions within water molecules. Heat is then subsequently
transferred into neighboring tissues (32,33). Due to the
increased depth of penetration, the unipolar treatment head
has been investigated for the improvement of the appearance
of cellulite (31,32).
Due to the lack of melanin absorption by RF energy, all skin
types can be successfully treated (33). The Accent XL UniPolar
treatment head has an integrated cooled treatment tip to
increase patient comfort. The unipolar RF energy is delivered
up to 200 W. Prior to initiation of treatment, mineral oil is
applied to the treatment area. The operator moves the hand-
piece across the treatment (6 in. × 10 in. gridded) area in
30-second passes in a circular fashion. Consecutive passes
are applied to the gridded area until the treatment end point
(40-43°C, measured via IR thermometer) is achieved (34).
Treatment sessions are performed every other week for up to
3 to 4 months (34). Transient erythema is common and expected.
Crusting, blistering, scarring, dyspigmentation, pain, and ecchy-
moses are potential adverse events associated with unipolar RF
treatment (31-33).
Alexiades-Armenakas and colleagues assessed 10 female
patients with cellulite distributed over the thighs using a
novel cellulite grading scale (0-4), which refl ected the appear-
ance of contours and dimple depth, density, and distribution.
In a randomized, split-leg manner, all patients received a
mean of 4.22 (range, 3-6) treatments (administered every
other week) to the investigational limb with the untreated leg
serving as a control. Unipolar RF energy was emitted at 150-
200 W per 30-second pass. Two blinded physicians assessed
photographs at each treatment and 1 and 3 months after the
last treatment. Three months after the fi nal treatment, dim-
ple density, distribution, and depth improved by 11.25%,
10.75%, and 1.75-2.5%, respectively. Overall, an average
7.83% improvement in the appearance of cellulite was dis-
covered on the treated leg; however, statistical signifi cance
was not obtained. While the majority of patients demon-
strated transient erythema, no episodes of scarring, crusting,
or dyspigmentation developed (31).
Thirty patients with moderate-to-severe thigh cellulite were
treated every other week for 3 months with 150-170 W of uni-
polar RF. All areas were treated with three passes and 30 sec-
onds per pass. Patients were evaluated 6 months after the fi nal
treatment via photography, MRI, plasma lipids, and skin
biopsy. No changes in plasma lipids or occurrence of blister-
ing, dyspigmentation, or scarring were observed. MRI evalua-
tions at the conclusion of the study failed to reveal a change in
the subcutaneous tissue. Fibroplasia of the dermis was noted
on histologic examination at 6 months after the fi nal treat-
ment. No changes were present in the subcutaneous tissue on
histology. Using standardized digital photography, performed
at baseline and 6 months after the fi nal treatment, the mean
cellulite improvement was 2.9 (as graded on a 4-point scale).
The authors concluded the longevity of results seen in this
VelaShape
VelaShape (Syneron Medical Ltd., Yokneam Illit, Israel) is an
FDA class II-cleared device for the noninvasive temporary cir-
cumferential reduction in thigh size and temporary cellulite
reduction, based on the same combination of bipolar RF, IR
light (700-2000 nm), vacuum, and mechanical tissue manipu-
lation as the original VelaSmooth device. The VelaShape plat-
form combines the previous VelaSmooth treatment head
along with a smaller (30 mm × 30 mm) treatment head, the
VelaContour.
VelaShape II is a newer version of the original VelaShape,
with 20% more power allowing for shorter treatment sessions,
as well as an improved interface terminal to optimize treat-
ments and facilitate device maintenance. The applicator heads
have different energy and vacuum parameters. On the VelaS-
hape II platform, the VelaContour is able to achieve up to 440
mbar of negative pressure, 20-W peak IR energy, and 23-W
peak RF energy, whereas the VelaSmooth is able to achieve up
to 380 mbar of negative pressure, 35-W IR energy, and 60-W
RF energy. Instructions for the use of the VelaSmooth are
identical to that listed above in the previous section. Addi-
tional instructions for VelaShape are as follows: large areas
(such as the waist, hips, and thighs) are treated with the VelaS-
mooth applicator for the majority of the treatment session. In
curved, small areas such as the lower abdomen and the peri-
umbilical area, and/or over local fatty deposits, the VelaCon-
tour applicator is used instead. For the VelaContour, treatment
is identical to the VelaSmooth; however, a 20% overlap is rec-
ommended with the VelaContour. With the new higher energy
VelaShape II, treatments are delivered at weekly intervals
(VelaShape II User Manual, 2009). Clinical studies with these
newer devices are presently underway. In our offi ce, we see a
signifi cant improvement over the VelaSmooth.
Accent
The Accent XL platform (Alma Lasers Ltd., Caesarea, Israel)
consists of two treatment heads, one employing unipolar
