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Synergistic Multi-polar Radiofrequency and Pulsed Magnetic Fields in the Non-
           Invasive Treatment of Skin Laxity and Body Contouring.

                   R. Stephen Mulholland, MD, Plastic Surgeon, Toronto Canada


INTRODUCTION                                             Radiofrequency energy devices have remained the
                                                         most common and dominant technology in the non-
Much of the surgical effort in Plastic Surgery and       invasive management of skin tightening, wrinkle
Cosmetic Medicine is devoted to the enhancement          reduction, cellulite improvement and body
of patients with skin laxity and/or body contouring      contouring enhancement, as they can treat all these
concerns. The gold standard of skin laxity therapy       conditions with relatively consistent results.
has always been, and remains, skin excision.             Radiofrequency (RF) devices may be mono polar,
Whether facelift, breast-lift, abdominoplasty or         bipolar (with or without other energy sources
brachioplasty, the removal of excess skin, through       synergistically pulsed), tri-polar or, now, multi-polar.
well-placed incisions, most often results in excellent   The RF energy is high frequency alternating
clinical results and a happy patient. Similarly, the     electrical current that passes into the dermis and
most consistent and impressive results in the            hypodermal tissues without disruption of the
management of multifocal lipodystrophy, with good        epidermal-dermal barrier. The high frequency
skin tone, remains the various techniques of             oscillating electrical current results in collisions
liposuction. However, the scars, stigmata, morbidity     between charged molecules and ions and the micro-
and fear of excisional and liposuction procedures        molecular mechanical energy from these collisions is
keep the majority of patients looking for less           transformed into heat1,2,3. This biological RF heat
invasive skin tightening and body contouring             occurs irrespective of chromophore or skin type and
procedures, away from the plastic surgeons and           is not dependent upon selective photothermolysis.
cosmetic physician offices that do not offer these       The RF heat has different biological and hence,
modalities.                                              clinical effects, depending upon the tissue targeted.
The consumer demand for, and hence the sales of          In the dermis, where the primary cellular element is
non-invasive devices for skin tightening, wrinkle        the fibroblast and the extracellular matrix (ECM) is
reduction, body contouring and cellulite                 comprised of collagen, elastin and ground
enhancement remain very strong, despite the              substances, the RF mediated thermal stimulation of
disruptive economy of the past three years. The          the ECM results in an immediate and temporary
ideal technology in this space would address skin        shrinkage of the collagen triple helix1,2,3. Further, the
tightening, cellulite improvement and body               RF thermal stimulation results in a micro-
contouring in one device, with efficacious,              inflammatory stimulation of the fibroblast which in
expeditious treatments and little discomfort. Such       response produces new collagen (neocollagenesis)
technology would have no disposables and would           and new elastin (neoelastogenesis), and ground
be affordable to the physician.                          substances2,3. If the RF thermal dermal stimulation
                                                         treatments are performed with enough frequency,
BASIC SCIENCE                                            duration and supra-physiological impact, then the
                                                         dermis will exhibit, over time, enhanced tensile
The technology options in the skin tightening and        strength, elastic properties from the newly produced
body contouring space have included vacuum               proteins and protogylcans, and will appear clinically
massage, infrared laser technologies, high               smoother and more youthful1,2,4. RF thermal
frequency focused ultrasounds, cryolipolysis,            stimulation of adipose tissue results in a thermal
radiofrequency energy and various hybrid energy          mediated stimulation and augmented activity of
device options.                                          Lipase mediated enzymatic degradation of
                                                         adipocyte derived Triglycerides into free fatty acids
                                                         and glycerol4.
This amplification of the physiologic breakdown and       Theoretically then, the Synergistic RF and Pulsed
egress of the Triglycerides out of the adipocyte,         Magnetic Fields would create RF thermal collagen
while keeping the adipocyte cell membrane and cell        stimulation and Pulsed Magnetic Field non-thermal
function intact, results in RF induced shrinkage of       stimulation of collagen, RF thermally mediated
the fat cells and body contouring and cellulite           reduction in adipose size and Pulsed Magnetic Field
improvements.                                             micro-tissue healing effects to minimize edema,
                                                          swelling and downtime that are associated with pure
THE VENUS FREEZE DEVICE                                   RF thermal therapies.

This paper introduces a novel RF device, the Venus        This paper reviews our clinical experience with the
Freeze® (Venus Concept Ltd., Israel) that combines        Freeze, synergistically utilizing Multi-polar RF and
Multi-Polar RF current and Pulsed Magnetic Fields         Pulsed Magnetic Fields in the treatment of skin
in synergy. The company calls this synergistic Multi      laxity, rhytides, as well as circumferential body
Polar Magnetic Pulsed technology (MP)2. The               contouring and cellulite.
Freeze system delivers the energy through hand
held applicators with Multi-polar electrodes. There is    MATERIALS AND METHODS
a larger Octipolar applicator with 8 electrodes
arranged in a circle, designed for the treatment of       The study is a cohort study of 15 patients that were
larger zones and body contouring, and a smaller           treated with the Freeze Multi-polar RF and Pulsed
applicator with 4 electrodes for the treatment of face,   Magnetic Fields device. 14 patients were female and
neck laxity and rhytides, and smaller body                1 patient was male. The age range was 30-66 years
contouring areas. Each magnetized electrode               old. Patients were weighed and photographed
simultaneously emits RF and a Pulsed Magnetic             before and after the study and were instructed to
Field. The RF current is produced between any two         continue with their current lifestyle and not to
electrodes in the array and by rapidly alternating RF     change their nutrition, caloric intake or physical
current between the different electrodes, the device      activity routines. 7 patients had their face and neck
can raise the temperature of treatment area quickly       treated for skin tightening and rhytide reduction. 8
and homogenously, without the RF focal “hot spots”        patients had treatments on their abdomen and hips
and pain seen with other RF devices.                      for circumferential reduction. Finally, 8/15 patients
                                                          also had synchronous treatments performed on an
The Pulsed Magnetic Field is induced by short             additional site for cellulite.
pulses of electrical current through coil in the
applicator. The magnetic field penetrates into the        All study patients were treated for 8 weeks, twice the
skin and results in Foucault (Eddy) electrical            first week, then once weekly for 7 weeks, using the
currents around the cell membranes of the treated         following protocol. Body areas were treated for 10
tissues. Foucault currents change the electrical          minutes for a 20 X 25 cm area. Facial treatments
potential of charged receptors on the bi-lipid cell       were performed for 12 minutes for each side of the
membrane layer of dermal cells, which results in the      face and 6 minutes for each side of the neck. The
stimulation of molecular and cellular activities and      patients were treated lying down comfortably, with
reactions5,6,7.                                           the treatment area exposed. After turning on the
Magnetic Fields have been shown to increase               device, the relevant treatment program was selected
fibroblast derived collagen production through a          from the available treatment options, and correct
non-thermal mechanism of membrane stimulation,            treatment head (OctiPolar or DiamondPolar
and the stimulation of fibroblast mediated                applicator) was selected. The treatment area was
angiogenesis, and hence facilitate and enhance            cleaned with an alcohol wipe and make up was
wound healing in tissues5,6,7.                            removed. Glycerin was applied to the treatment
                                                          area.
The energy and treatment times were adjusted               CONCLUSIONS
according to the area being treated. The starting
energy was 30% for the face and 50% for the body.          The use of a synergistic Multi-polar Radiofrequency
The applicator was applied to the skin, and the area       and Pulsed Magnetic Field device (The Freeze)
was treated using sweeping motions. Applicator was         appears to produce consistent and demonstrable
not allowed to stop moving. The treatment                  skin tightening, circumferential reduction and
technician deployed continuous sweeping motions,           cellulite improvement. When compared to other RF
“figure 8”, “swirls”, “snakes” and “wave” shaped           devices on the market, the Freeze appears to have
movements. During treatment, the energy was                the following advantages:
adjusted up or down, as tolerated, to achieve at           1. Freeze works much faster to achieve the thermal
least 40-42°C epidermal temperature within the first           endpoint.
few minutes of treatment, and throughout the entire        2. The soft tissue heating is more uniform and
treatment. Infrared thermometer was deployed to                therefore is much more tolerable by the patient.
measure the epidermal temperature. Treatment               3. The device and treatments appear very safe.
endpoint was 10 minutes of treatment per area with         4. The Freeze device has versatile clinical
a uniform temperature of 40-42°C throughout the                applications and revenue streams through the
surface area.                                                  use of the DiamondPolar and OctiPolar
All patients had before and after photography taken.           applicators. Face and neck aging concerns, as
The body contouring patients had circumferential               well as small and large zone lipodystrophy and
measurements taken of the treatment zones.                     cellulite, can be treated.
                                                           5. Consistent and efficacious outcomes are
RESULTS                                                        achieved.
                                                           6. The Ergonomically designed applicators are
All patients completed the study and follow-up                 friendly and easy to use by technicians.
photographs were taken at 3 months following last          7. No disposable cost to the physician.
treatment. The author reviewed all facial
photographs for evidence of wrinkle reduction and          Synergistic Multi-polar RF and Pulsed Magnetic
facial and cervical skin tightening. All skin tightening   Field treatments can be a versatile, efficacious and
patients (7/7) demonstrated moderate to significant        economically desirable addition to an aesthetic
visual improvements in their rhytides, laxity and          medical practice.
facial contours (figure 1).
The average circumferential reduction for the              REFERENCES
abdominal-hip body contour patients was 3.1cm
(range 1.4cm – 4.3cm). All body contouring patients        1. Alster, TS, Lupton JR. Nonablative cutaneous
(8/8) responded with some measurable                          remodeling using radiofrequency devices. Clin
circumferential reduction (Figure 2).                         Dermatol 2007;25:487-91.
                                                           2. Zelickson BD, Kist D, Bernstein E, et al.
For the cellulite cohort, 6/8 patients demonstrated           Histological and ultrastructural evaluation of the
noticeable and pleasing improvement in the                    effects of a radiofrequency based non-ablative
appearance of their cellulite (Figure 2). The                 dermal remodeling device: a pilot study. Arch
treatments were well tolerated, there were no                 Dermatol. 2004;140:204-9.
complaints of significant pain or discomfort during        3. Hantash BM, Ubeid AA, Chang H, et al. Bipolar
any treatment, no major complications reported and            fractional radiofrequency treatment induces
only two cases of minor erythema reported on face             neoelastogenesis and neocollagenesis. Lasers
or neck treatments that resolved within one hour.             Surg Med. 2009;41:1-9.
4. Emilia del Pino, M, Rosado RH, Azuela A, et al.
   Effect of controlled volumetric tissue heating with
   radiofrequency on cellulite and subcutaneous
   tissue of the buttocks and thighs. J Drugs and
   Dermatol. 2006;5:714-22.
5. Akira Soda et al. Effect of exposure to an
   extremely low radiofrequency-electromagnetic
   field on the cellular collagen with respect to
   signaling pathways in osteopath-like cells. J Med
   Invest. 2008;55:267-78.
6. Murray JC, Farndale RW. Modulation of collagen
   production in cultured fibroblasts by a low-
   frequency, pulsed magnetic field. Biochem
   Biophys Acta. 1985 Jan 28;838:98-105.
7. Tepper OM, Callaghan MJ, Chang EL, et al.
   Electromagnetic fields increase in vitro and in
   vivo angiogenesis through endothelial release of
   FGF-2. FASEB J 2004; 18:1231-3.




                     Figure 1




                     Figure 2

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Dr mulholland

  • 1. Synergistic Multi-polar Radiofrequency and Pulsed Magnetic Fields in the Non- Invasive Treatment of Skin Laxity and Body Contouring. R. Stephen Mulholland, MD, Plastic Surgeon, Toronto Canada INTRODUCTION Radiofrequency energy devices have remained the most common and dominant technology in the non- Much of the surgical effort in Plastic Surgery and invasive management of skin tightening, wrinkle Cosmetic Medicine is devoted to the enhancement reduction, cellulite improvement and body of patients with skin laxity and/or body contouring contouring enhancement, as they can treat all these concerns. The gold standard of skin laxity therapy conditions with relatively consistent results. has always been, and remains, skin excision. Radiofrequency (RF) devices may be mono polar, Whether facelift, breast-lift, abdominoplasty or bipolar (with or without other energy sources brachioplasty, the removal of excess skin, through synergistically pulsed), tri-polar or, now, multi-polar. well-placed incisions, most often results in excellent The RF energy is high frequency alternating clinical results and a happy patient. Similarly, the electrical current that passes into the dermis and most consistent and impressive results in the hypodermal tissues without disruption of the management of multifocal lipodystrophy, with good epidermal-dermal barrier. The high frequency skin tone, remains the various techniques of oscillating electrical current results in collisions liposuction. However, the scars, stigmata, morbidity between charged molecules and ions and the micro- and fear of excisional and liposuction procedures molecular mechanical energy from these collisions is keep the majority of patients looking for less transformed into heat1,2,3. This biological RF heat invasive skin tightening and body contouring occurs irrespective of chromophore or skin type and procedures, away from the plastic surgeons and is not dependent upon selective photothermolysis. cosmetic physician offices that do not offer these The RF heat has different biological and hence, modalities. clinical effects, depending upon the tissue targeted. The consumer demand for, and hence the sales of In the dermis, where the primary cellular element is non-invasive devices for skin tightening, wrinkle the fibroblast and the extracellular matrix (ECM) is reduction, body contouring and cellulite comprised of collagen, elastin and ground enhancement remain very strong, despite the substances, the RF mediated thermal stimulation of disruptive economy of the past three years. The the ECM results in an immediate and temporary ideal technology in this space would address skin shrinkage of the collagen triple helix1,2,3. Further, the tightening, cellulite improvement and body RF thermal stimulation results in a micro- contouring in one device, with efficacious, inflammatory stimulation of the fibroblast which in expeditious treatments and little discomfort. Such response produces new collagen (neocollagenesis) technology would have no disposables and would and new elastin (neoelastogenesis), and ground be affordable to the physician. substances2,3. If the RF thermal dermal stimulation treatments are performed with enough frequency, BASIC SCIENCE duration and supra-physiological impact, then the dermis will exhibit, over time, enhanced tensile The technology options in the skin tightening and strength, elastic properties from the newly produced body contouring space have included vacuum proteins and protogylcans, and will appear clinically massage, infrared laser technologies, high smoother and more youthful1,2,4. RF thermal frequency focused ultrasounds, cryolipolysis, stimulation of adipose tissue results in a thermal radiofrequency energy and various hybrid energy mediated stimulation and augmented activity of device options. Lipase mediated enzymatic degradation of adipocyte derived Triglycerides into free fatty acids and glycerol4.
  • 2. This amplification of the physiologic breakdown and Theoretically then, the Synergistic RF and Pulsed egress of the Triglycerides out of the adipocyte, Magnetic Fields would create RF thermal collagen while keeping the adipocyte cell membrane and cell stimulation and Pulsed Magnetic Field non-thermal function intact, results in RF induced shrinkage of stimulation of collagen, RF thermally mediated the fat cells and body contouring and cellulite reduction in adipose size and Pulsed Magnetic Field improvements. micro-tissue healing effects to minimize edema, swelling and downtime that are associated with pure THE VENUS FREEZE DEVICE RF thermal therapies. This paper introduces a novel RF device, the Venus This paper reviews our clinical experience with the Freeze® (Venus Concept Ltd., Israel) that combines Freeze, synergistically utilizing Multi-polar RF and Multi-Polar RF current and Pulsed Magnetic Fields Pulsed Magnetic Fields in the treatment of skin in synergy. The company calls this synergistic Multi laxity, rhytides, as well as circumferential body Polar Magnetic Pulsed technology (MP)2. The contouring and cellulite. Freeze system delivers the energy through hand held applicators with Multi-polar electrodes. There is MATERIALS AND METHODS a larger Octipolar applicator with 8 electrodes arranged in a circle, designed for the treatment of The study is a cohort study of 15 patients that were larger zones and body contouring, and a smaller treated with the Freeze Multi-polar RF and Pulsed applicator with 4 electrodes for the treatment of face, Magnetic Fields device. 14 patients were female and neck laxity and rhytides, and smaller body 1 patient was male. The age range was 30-66 years contouring areas. Each magnetized electrode old. Patients were weighed and photographed simultaneously emits RF and a Pulsed Magnetic before and after the study and were instructed to Field. The RF current is produced between any two continue with their current lifestyle and not to electrodes in the array and by rapidly alternating RF change their nutrition, caloric intake or physical current between the different electrodes, the device activity routines. 7 patients had their face and neck can raise the temperature of treatment area quickly treated for skin tightening and rhytide reduction. 8 and homogenously, without the RF focal “hot spots” patients had treatments on their abdomen and hips and pain seen with other RF devices. for circumferential reduction. Finally, 8/15 patients also had synchronous treatments performed on an The Pulsed Magnetic Field is induced by short additional site for cellulite. pulses of electrical current through coil in the applicator. The magnetic field penetrates into the All study patients were treated for 8 weeks, twice the skin and results in Foucault (Eddy) electrical first week, then once weekly for 7 weeks, using the currents around the cell membranes of the treated following protocol. Body areas were treated for 10 tissues. Foucault currents change the electrical minutes for a 20 X 25 cm area. Facial treatments potential of charged receptors on the bi-lipid cell were performed for 12 minutes for each side of the membrane layer of dermal cells, which results in the face and 6 minutes for each side of the neck. The stimulation of molecular and cellular activities and patients were treated lying down comfortably, with reactions5,6,7. the treatment area exposed. After turning on the Magnetic Fields have been shown to increase device, the relevant treatment program was selected fibroblast derived collagen production through a from the available treatment options, and correct non-thermal mechanism of membrane stimulation, treatment head (OctiPolar or DiamondPolar and the stimulation of fibroblast mediated applicator) was selected. The treatment area was angiogenesis, and hence facilitate and enhance cleaned with an alcohol wipe and make up was wound healing in tissues5,6,7. removed. Glycerin was applied to the treatment area.
  • 3. The energy and treatment times were adjusted CONCLUSIONS according to the area being treated. The starting energy was 30% for the face and 50% for the body. The use of a synergistic Multi-polar Radiofrequency The applicator was applied to the skin, and the area and Pulsed Magnetic Field device (The Freeze) was treated using sweeping motions. Applicator was appears to produce consistent and demonstrable not allowed to stop moving. The treatment skin tightening, circumferential reduction and technician deployed continuous sweeping motions, cellulite improvement. When compared to other RF “figure 8”, “swirls”, “snakes” and “wave” shaped devices on the market, the Freeze appears to have movements. During treatment, the energy was the following advantages: adjusted up or down, as tolerated, to achieve at 1. Freeze works much faster to achieve the thermal least 40-42°C epidermal temperature within the first endpoint. few minutes of treatment, and throughout the entire 2. The soft tissue heating is more uniform and treatment. Infrared thermometer was deployed to therefore is much more tolerable by the patient. measure the epidermal temperature. Treatment 3. The device and treatments appear very safe. endpoint was 10 minutes of treatment per area with 4. The Freeze device has versatile clinical a uniform temperature of 40-42°C throughout the applications and revenue streams through the surface area. use of the DiamondPolar and OctiPolar All patients had before and after photography taken. applicators. Face and neck aging concerns, as The body contouring patients had circumferential well as small and large zone lipodystrophy and measurements taken of the treatment zones. cellulite, can be treated. 5. Consistent and efficacious outcomes are RESULTS achieved. 6. The Ergonomically designed applicators are All patients completed the study and follow-up friendly and easy to use by technicians. photographs were taken at 3 months following last 7. No disposable cost to the physician. treatment. The author reviewed all facial photographs for evidence of wrinkle reduction and Synergistic Multi-polar RF and Pulsed Magnetic facial and cervical skin tightening. All skin tightening Field treatments can be a versatile, efficacious and patients (7/7) demonstrated moderate to significant economically desirable addition to an aesthetic visual improvements in their rhytides, laxity and medical practice. facial contours (figure 1). The average circumferential reduction for the REFERENCES abdominal-hip body contour patients was 3.1cm (range 1.4cm – 4.3cm). All body contouring patients 1. Alster, TS, Lupton JR. Nonablative cutaneous (8/8) responded with some measurable remodeling using radiofrequency devices. Clin circumferential reduction (Figure 2). Dermatol 2007;25:487-91. 2. Zelickson BD, Kist D, Bernstein E, et al. For the cellulite cohort, 6/8 patients demonstrated Histological and ultrastructural evaluation of the noticeable and pleasing improvement in the effects of a radiofrequency based non-ablative appearance of their cellulite (Figure 2). The dermal remodeling device: a pilot study. Arch treatments were well tolerated, there were no Dermatol. 2004;140:204-9. complaints of significant pain or discomfort during 3. Hantash BM, Ubeid AA, Chang H, et al. Bipolar any treatment, no major complications reported and fractional radiofrequency treatment induces only two cases of minor erythema reported on face neoelastogenesis and neocollagenesis. Lasers or neck treatments that resolved within one hour. Surg Med. 2009;41:1-9.
  • 4. 4. Emilia del Pino, M, Rosado RH, Azuela A, et al. Effect of controlled volumetric tissue heating with radiofrequency on cellulite and subcutaneous tissue of the buttocks and thighs. J Drugs and Dermatol. 2006;5:714-22. 5. Akira Soda et al. Effect of exposure to an extremely low radiofrequency-electromagnetic field on the cellular collagen with respect to signaling pathways in osteopath-like cells. J Med Invest. 2008;55:267-78. 6. Murray JC, Farndale RW. Modulation of collagen production in cultured fibroblasts by a low- frequency, pulsed magnetic field. Biochem Biophys Acta. 1985 Jan 28;838:98-105. 7. Tepper OM, Callaghan MJ, Chang EL, et al. Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. FASEB J 2004; 18:1231-3. Figure 1 Figure 2