http://www.icosmed.de Abstract: This pilot study was conducted to evaluate the thermal effect and immediate response of human adipose tissue to RF energy applied during minimally invasive liposuction. The preliminary investigation showed efficiency of RF energy in creating the desired thermal effect, specifically effective pre-aspiration thermal coagulation of adipose and vascular tissue with uniform heating of the skin!"

1. Pilot!Evaluation!of!Radio"Frequency!Assisted!Liposuction!(RFALTM)!
!Malcolm!Paul,!MD.!R!Stephen!Mulholland,!MD.!!Newport!Beach,!CA,!and!Toronto!Canada!
Abstract: This pilot study was conducted to evaluate the thermal effect and immediate response of human
adipose tissue to RF energy applied during minimally invasive liposuction. The preliminary investigation
showed efficiency of RF energy in creating the desired thermal effect, specifically effective pre-aspiration
thermal coagulation of adipose and vascular tissue with uniform heating of the skin!"#$%&'!(!)%*+,#-.%+&!
*$+-/"#$/0
Introduction! Materials!and!Methods!
Liposuction is the most popular cosmetic surgical The RFAL! procedure was performed on 4
procedure. 1&! .2/! 3&%./"! 4.(./,! ()+&/5! &/($)6! patients using the BodyTiteTM system (Invasix
7895999! )%*+*)(,.6! *$+-/"#$/,! ($/! */$:+$;/"! Ltd.). The internal electrode was inserted into the
(&&#())6. <(-=!+:!,=%&!/)(,.%-%.6!$/;(%&,!+&/!+:! adipose tissue at the desired depth as shown in
.2/!;+,.!-+;;+&!$/)(.%>/!-+&.$(%&"%-(.%+&,!:+$! figure 2.
)%*+,#-.%+&0
There are many non-invasive devices which can
demonstrate ,+;/! ,=%&! .%'2./&%&'! (:./$! .2/$;()!
-#.(&/+#,! .$/(.;/&.! #,%&'! .$(&,/*%"/$;()! ?@!
(&"! )(,/$! /&/$'60! 1&-+$*+$(.%&'! .2%,! .2/$;())6!
;/"%(./"! "/$;()! (&"! ,+:.! .%,,#/! -+&.$(-.%+&!
/::/-.!%&.+!(!)%*+,#-.%+&!*$+-/"#$/!;(6!*$+>%"/!
,%'&%:%-(&.!,=%&!.%'2./&%&'!A/&/:%.,!:+$!*(.%/&.,.
Recently, LAL, specifically Smartlipo™ has Figure 1. Bipolar RF hand piece inserted into the
$/-/%>/"! (! )+.! +:! ;/"%(! (../&.%+&! (&"! '(%&/"! body.
,.$+&'!*26,%-%(&!*+*#)($%.6!%&!-+,;/.%-!,#$'/$6! This insulated internal electrode probe emits the RF
BCDEF0! G2/! ;(%&! $/(,+&! :+$! .2/! ,#$'/! %&! current through a small conductive tip. The
*+*#)($%.6!%,!.2/!*$+*+,%.%+&!(&"!/H*/-.(.%+&!+:!! external electrode has a larger contact area and is
(! '/&.)/$! -+&.+#$%&'! *$+-/"#$/! (&"! ,=%&! applied to the skin surface creating lower power
.%'2./&%&'!%;*$+>/;/nt as result of laser thermal density in the skin than in the adipose tissue. 40
effect on collagen and connective tissue. Watts of RF power was applied between .2/! two
LAL is based on manual coverage of the electrodes.
subcutaneous treatment volume with optical fiber The BodyTite device provides online, continuous
delivering laser radiation through a very small area skin temperature measurements with a negative
fiberoptic, having "%(;/./$!+:!I99!;%-$+&,0! feedback loop control of power
G2/! ;(%&! $/*+$./"! )%;%.(.%+&! +:! .2/! <J<! %,! During the treatment the parameters of the
$/)(.%>/)6! )+&'! .$/(.;/&.! .%;/! B8F! (&"! :+-()! BodyTite device were set so that the system would
A#$&,0! reach 40-EM+N! (&"! ;(%&.(%&! .2(.! .($'/.!
1&! .2%,! -#$$/&.! $/*+$.5! K/! ,#;;($%L/! +#$! ./;*/$(.#$/!:+$!(!-+&,%,./&.!*/$%+"!+:!.%;/0!!
*$/)%;%&($6! "(.(! +&! .2/! #,/! +:! ?@! /&/$'6! :+$! In the current study we did not have objectives to
,%;#).(&/+#,!)%*+)6,%,5!>(,-#)($!-+('#)(.%+&!(&"! evaluate the long term clinical effects, as our
,=%&! 2/(.%&'0 The underlying concept of the primary purpose was to test a new technology and
treatment is based upon accurate, monitored and its ability to create a #&%:+$;!.2/$;()!/::/-.!+:!.2/!
controlled pre-aspiration thermal destruction and .$/(./"! ($/(! %&! (! -+&,%,./&.! (&"! .%;/! /::%-%/&.!
coagulation of the adipose and vascular tissue with ;(&&/$0! O/! A/)%/>/! .2(.! .2%,! %,! .2/! A(,%,! :+$!
sub-necrotic heating of the dermis using RF /::/-.%>/! )%*+)6,%, and skin tightening without
energy. significant risk of dermal injury. 4 patients
underwent RFAL. All patients were female, with
an average age of 42 years old. Two patients
underwent outer thigh procedures and two hip and
abdomen RFAL treatments.

2. We made evaluation of technologies using two
treatment protocols:
1. In the first case we divided treatment areas of
thermal zones with size of 5x5cm. Each zone
was treated until skin temperature reached the
end point of 40oC. The same thermal grid
protocol was used in the LAL treatment.
2. The thermal elevation was so fast with the small
5 X 5cm grid protocol, that a second
evaluation of larger thermal zones of
10x15cm were treated with the same thermal
end point.
For both cases skin temperature was monitored by
thermal camera and confirmed with a hand held
infrared thermometer.
In order to assess the optimal parameters, efficacy,
and safety while avoiding any side effects to the
skin, .2/!.$/(.;/&.,!K/$/!%&%.%())6!*/$:+$;/"!+&!
.K+! *$/D/H-%,%+&! (A"+;%&+*)(,.6! ,*/-%;/&,5!
K%.2! (! :(.! )(6/$! +:! M8DP9;;0! G#;/,-/&.!
(&(/,.2/,%(! K(,! (**)%/"! *$%+$! .+! .2/! ?@J<!
.$/(.;/&.0! ! J:./$! -+&:%$;(.%+&! +:! *($(;/./$!
,(:/.6! (&"! /::%-(-6! 5! ?@J<! K(,! */$:+$;/"! +&! E! Figure 2. Typical thermal image of the small
*(.%/&.,0! treated zone at after 30sec (top), 60sec(center) and
Q#$! +AR/-.%>/! K(,! .+! (&()6L/! .2/! ./;*/$(.#$/! after 180sec (bottom).
"%,.$%A#.%+&!%&!.2/!.$/(.;/&.!($/(5!(,,#;%&'!.2/! G2/!.$/(.;/&.!+:!,#-2!(!,;())!G2/$;()!L+&/!K(,!
%;*+$.(&-/! +:! .2/! .2/$;()! /::/-.! :+$! ,=%&! &+.! >/$6! /::%-%/&.! A/-(#,/! +:! .2/! "%::%-#).6!
.%'2./&%&'!(&"!.+!/&,#$/!/($)6!S#()%.6!+#.-+;/,0! -+&.$+))%&'!,;())!2(&"*/%-/!;+>/;/&.,!(&"!.2/!
$(*%"!$%,/!%&!./;*/$(.#$/0!
Results!and!Discussion! Heating to a significant target temperature in each
Small!zone!treatment! thermal zone was very fast but high speed thermal
G2/! 1&%.%()! ./;*/$(.#$/! +:! .2/! ,=%&! *$%+$! .2/! heating did not result in the appearance of “hot
.$/(.;/&.!K(,!%&!.2/!$(&'/!+:!M7+N!.+!MT+N0!! spots”, or areas of focal thermal excess, which is
common with LAL. After 60 sec skin temperature
G2/!?@J<!"/>%-/!#,/"!(!*+K/$!+:!E9O0!U/,%$/"!
reached 40-42oC and this target temperature was
./;*/$(.#$/! K(,! $/(-2/"! %&! I9,/-0! J:./$! .2%,! able to be maintained for several minutes over the
.%;/! */$%+"! K/! -+&.%&#/"! .2/! .$/(.;/&.! +:! .2/! entire treatment areas, with continuous feedback
L+&/! :+$! (""%.%+&()! M! ;%&#./,0! U#$%&'! .2%,! temperature control.
;(%&./&(&-/! */$%+"5! .2/! V+"6G%./! "/>%-/!
("R#,./"! ?@! *+K/$! (#.+;(.%-())6! .+! ;(%&.(%&! BodyTite!treatment!protocol!
,=%&!./;*/$(.#$/!(.!*$/"/./$;%&/"!)/>/). Figure ?@J<! .$/(.;/&.! +:! (! )($'/! C8-;! W! C9-;! ($/(!
2 shows thermal images of skin surface during the K(,! S#%./! /::/-.%>/5! :(,.! (&"! #&%:+$;!. After 5-6
treatment. min and an average of 15KJ at 40W, the
temperature of the zone reached end point of 40-
42oC. Figure 3 shows thermal distribution of
treated area before the treatment and after 90sec,
210sec and 300sec after the beginning of the
treatment

3. coagulation of fat and blood vessels post RFAL
treatment. Figure 4 shows a cross section of
abdominal tissue with RFAL treated and non-
treated zones.
One can see that after the RFAL treatment blood
content is significantly reduced due to coagulation
of blood vessels by the RF current, which acts in
the same manner as surgical RF bipolar
electrocautery. During aspiration of the RFAL
cases, the color of fat was devoid of blood after the
treatment indicating its coagulation.
We noted that the subdermal vascular plexus and
arcade was not damaged and bleeding of the skin
was normal indicating safety of the method for the
skin.
The four RFAL patients underwent their body
contouring procedure without complication. The
postoperative reports of pain, discomfort and
bruising were remarkably diminished and good
early skin contraction was achieved.
Figure 4. Cross-section of human fat and skin
Figure 3. Thermal image of the large treated zone Top-untreated tissue, Bottom-RFAL treated tissue
before the treatment and at after 90sec, 210sec
and 300sec (from top down).
The thermal video images of the treated zones
reveal an extremely uniform temperature Figure 5 shows a patient who underwent a RFAL
distribution. Hot liquefied fat was observed leaking outer thigh reduction with
from the incision port on the thermal images. excellent early results and another patent with
Observation of the post thermal coagulation and abdominal and hip contour enhancement and skin
aspirated adipose tissue, shows effective contraction.

4. Figure 5. Before (left) and 6 weeks post treatment (right) images for 2 patients treated with RFAL.
incorporated in RFAL!, minimally invasive body
Conclusion! contour procedures represents a significant advance
In this study we witnessed some significant in less morbid liposuction procedures and affords
advantages using RFAL technology including its optimal skin contraction for those patients with
ability to heat uniformly both small and larger questionable skin laxity.
thermal areas. RFAL demonstrated a very rapid
adipose heating speed with excellent uniformity. References!
Our early clinical experience suggests signification 1. Goldman A. Submental Nd:YAG Laser-assisted
skin contraction, but more quantitative and Liposuction. Lasers in Surg and Medicine. 38:181,
objective measurements of the! /::/-.! +:! .%,,#/! 2006.
2/(.%&'! +&! ,=%&! .%'2./&%&'! (&"! .2/! 2/()%&'! 2. Ichikawa, K., et al. Histological Evaluation of
*$+-/,,! K%))! A/! $/*+$./"! %&! :#$.2/$! Pulased Nd:YAG Laser for Lipolysis. Lasers in
%&>/,.%'(.%+&,0! 4=%&! -+&.$(-.%+&! (,%"/5! K/! Surg and Medicine. 36:43, 2005
A/)%/>/! .2(.! (! ;+$/! #&%:+$;! .2/$;()! ("%*+,/!
3. Zulmira, A, Badin D. Laser Lipolysis:Flaccidity
.%,,#/!(&"!A)++"!>/,,/)!-+('#)(.%+&!())+K,!:+$!(!
under control. Aesthetic Plast Surg 26:335, 2002.
)/,,! .$(#;(.%-! :(.! (,*%$(.%+&! K%.2! )/,,! A)//"%&'!
(&"! )/,,! *+,.! +*/$(.%>/! A$#%,%&', /"/;(! (&"! 4. Prado A, Andrades P, Danilla S, Leniz P,
*(%&. The RFAL technology demonstrated a Castillo P, Gaete F. A prospective, randomized,
tremendous ability to heat skin and sub-dermal fat double-blind, controlled clinical trial comparing
to the desired temperature and then, with a laser-assisted lipoplasty with suction-assisted
feedback control loop, maintain that temperature lipoplasty. Plast Reconstr Surg. 2006 Sep
for prolonged periods of time. It is both the 15;118(4):1032-45.
absolute temperature and the duration of exposure 5. Laser assisted lipolysis evolves Body
that will determine skin contraction after heating Contouring Arena, By Bob Kronemyer, Aesthetic
based liposuction procedures. We believe that the Guide Primary Care Edition, Volume 4, number 2,
safe, effective and rapid RF thermal component p.61.