Biomedical Engineering Reference
In-Depth Information
reported. Textural images showed elevations of depressed
areas and reduction of surface bulges. Computer-generated
volumetric analysis demonstrated a decrease in thigh volume.
At 6 months after the fi nal treatment, 94% of subjects reported
sustained improvement in the appearance of cellulite. Percen-
tile improvements based on quartile scales or a similar grading
system was not performed (23). Further studies evaluating the
clinical appearance of cellulite are necessitated.
should never be simultaneously set at maximum parameters.
In skin types IV-VI or tanned skin, the light should be set to
1-2. If the patient does not experience lasting erythema or
excessive heat, the level may be increased to 2-3 and the skin
response reevaluated. To increase the degree of patient com-
fort in sensitive areas, such as the inner thighs and abdomen,
the vacuum can be adjusted to a level 1 or 2. Adverse events
include erythema, pain, edema, bullae formation, scabbing,
ecchymoses, postinfl ammatory hyperpigmentation, and scar-
ring (24,25,27,28).
Thirty-fi ve female patients with cellulite of the thighs and/or
buttocks were treated in a two-arm, multicenter study by
Sadick and Mulholland. The fi rst group (
n
= 20) received
biweekly treatments for 4 weeks, whereas the second group
(
n
= 15) received biweekly treatments for 8 weeks. All patients
were treated with maximum tolerance parameters for all ener-
gies (RF maximum energy 20 W and optical maximum energy
of 20 W). Two patients developed crusting, which resolved
within 3 days. All patients were evaluated on a quartile scale
for percent improvement from baseline to 3-4 weeks after the
last treatment session. All patients demonstrated some
improvement in the appearance of cellulite. However, patients
treated with 16 treatments achieved higher levels of physician-
graded improvement, corresponding to a 50-75% or 75-100%
improvement (25).
Alster and Tanzi investigated 20 patients with moderate
thigh and buttock cellulite using biweekly VelaSmooth (20-W
RF, 20-W IR) treatments for 4 weeks. This study was con-
ducted in a randomized, split-leg manner with the untreated
leg serving as the control. Physician-graded improvement was
based on a quartile scale, similar to Sadick et al. Ten percent of
patients experienced ecchymoses. Ninety percent of subjects
experienced improvement in the appearance of cellulite on the
treated leg, with a mean improvement of nearly 50% at 1
month after the last treatment. All but one of these subjects
was interested in receiving treatments to the control leg. Of
note, at 3 and 6 months after the last treatment, the physician-
graded improvement scale decreased to approximately 35%
and 25%, respectively (24).
Sixteen patients were treated with biweekly treatments for
thigh cellulite for 4 weeks in a study by Kulick. All patients
were treated with maximal machine parameters using an RF
energy of 20 W and optical energy of 12.5 W. All patients were
followed for 6 months after their last treatment. Transient ery-
thema occurred posttreatment in all patients. Bruising
occurred in 32.25% of subjects but resolved within a week. A
single patient sustained a second-degree burn. At 3 and 6
months after the last treatment, the mean investigator-graded
improvement scores were 62% and 50%, respectively. At both
time points, all patients graded their cellulite to be improved
over 25% (27).
In a study by Boey, 17 women received VelaSmooth (using
the earlier, low-energy model) treatments for mild-to-moder-
ate cellulite on thighs, buttocks, and abdomen. The mean
investigator-graded improvement from baseline was 32.9%,
whereas the mean subject-graded improvement from baseline
was 30.6%. Follow-up times and a description of the treat-
ment regimen were not provided. Bruising was reported in
58.8% of patients but no crusting. The majority of patients
experienced temporary erythema and edema (28).
RF Energy Devices
VelaSmooth
VelaSmooth (Syneron Medical Ltd., Yokneam Illit, Israel) is based
on a combination of two different ranges of electromagnetic
energy, which produce heat: IR light and RF, known as ELOS.
VelaSmooth was the fi rst energy-based medical device to be
approved by the FDA for reducing the appearance of cellulite.
It is a device that combines controlled IR light (700-2000 nm,
in the most current model) and conducted bipolar RF energies
with mechanical manipulation of the skin to improve the
appearance of cellulite (24-26). In the most current model, the
VelaSmooth peak optical energy is 35 W and peak RF energy is
60 W. Prior models had a peak optical energy of 12.5-20 W
and a peak RF energy of 20-50 W.
By combining RF energy with optical energy, the required
amount of optical energy may be reduced. As a result, the
majority of skin types can be successfully treated as RF does
not target melanin and therefore the epidermal heating is
reduced. Manipulation is provided via vacuum suction and
mechanical rollers in a 40 mm × 40 mm applicator head.
Before initiating treatment, the skin should be cleaned. Con-
ductive lotion is applied to the treatment area and gel should
never be used. Once rehydrated, the skin does not need con-
stant reapplication of conductive lotion even if it appears dry;
the electrode rollers will remain coupled to the skin as long as
proper pressure and contact are made by the operator. How-
ever, additional lotion should be applied during treatment if
the applicator becomes diffi cult to move across the treatment
area. Proper applicator seal to the skin surface is indicated by a
lack of air being heard sucked into the chamber in addition to
a nonfl ashing light indicator on the applicator. For the effec-
tive and safe delivery of RF energy, ensure the RF rollers main-
tain equal compression and contact with the skin surface.
Each treatment area (i.e., posterior thigh, anterior thigh,
inner thigh, outer thigh/hip, buttocks) should be treated for 5
minutes with three to six passes of the VelaSmooth applicator.
The targeted end point is signifi cant erythema and warmth
(40-42°C, which is maintained for 5-10 minutes) of the treat-
ment area. The time for each treatment session is approxi-
mately 20-30 minutes per side of the body. With the most
current model of VelaSmooth, the manufacturer recommends
treatments once a week for 4-6 weeks; however, the majority
of studies have been performed using earlier, less powerful
models, using biweekly treatments for 4 weeks (24-27).
All three parameters on this device can be independently
adjusted to tailor treatment to each patient's needs. The treat-
ment levels on all three components range from 1 to 3. To
maximize the effectiveness of the device for the treatment of
cellulite, areas should be treated with the highest levels of light
and RF (as tolerated by the patient) with a vacuum level of
1-2, except in the following situations. All treatment levels
