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Lecture by Dr. Patrick Treacy to the London Aesthetic Conference in 2008 about UltraShape, which uses the new process of therapeutic ultrasound to remove unwanted fat.
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UltraShape®
the evidence
Internationally How big is the problem?
SURGICAL +118% in 7 years
NON-SURGICAL +763% in 7 years
Recent explosion of non-surgical devices
Non-SURGICAL
• Continue to grow quicker than surgical
• >4 x more common than surgical
– (ASAPS - USA 2004 12 million cosmetic
procedures - 2,1 Surgical and 9,7 nonsurgical)
• No or limited downtime
• High patient acceptance
Surgical procedures are objective with previous defined parameters. Minimal outlayIf done in hospital type setting
Problem… this has long downtime, higher morbidity and less patient acceptance
Key to success in any cosmetic procedure
…. a well informed patient with realistic expectations
… to be able to inform patients correctly we have to know the potentials and limitations of a non surgical aesthetic procedure. Thus carefully controlled and monitored studies are needed regarding UltraShape…
UltraShape®The clinical evidence
UltraShape® Multi-Center Controlled Clinical Trial Single-Treatment S.Teitelbaum (U.S.), J.Burns (U.S.), J.Otto (England), J.Kubota (Japan), Y.Shirakabe (Japan), S. Brown (U.S.) Enrolled: 164 Patients
Treated: Single treatment: abdomen, flanks, and thighs
Endpoint: Circumference reduction (standardized measuring
system) Fat thickness (ultrasonography-constant
pressure device)
Safety: Blood and urine analysis (including lipid profile),
liver ultrasound, pulse oximetry, 2-point
discrimination
Controls: Untreated control group
Internal controls: thigh circumference & weightTeitelbaum et al. PRS ‘07
Single treatment reduced circumference by 2 cm on avg.
Multi-Center Controlled Clinical Trial Multi-Center Controlled Clinical Trial UltraShapeUltraShape®® Single-Treatment Single-Treatment
Teitelbaum et al. PRS
Significant reduction in treatment area vs. internal control area
Multi-Center Controlled Clinical Trial Multi-Center Controlled Clinical Trial UltraShapeUltraShape®® Single-Treatment Single-Treatment
Teitelbaum et al. PRS
No significant weight change
Multi-Center Controlled Clinical Multi-Center Controlled Clinical Trial Trial UltraShapeUltraShape®® Single-Treatment Single-Treatment
Teitelbaum et al. PRS
Study Study Results
Pulse oximetry Normal
Liver ultrasound No treatment-induced change
Two-point discrimination No clinically significant change
UltraShape® Multi-Center Controlled Clinical Trial Single-Treatment
Teitelbaum et al. PRS
Efficacy82% demonstrated measurable circumference reduction 2.0 cm avg. reduction at 84 days (P value <0.01)
SafetyNo clinically significant elevation in lipid profilesNo clinically significant changes in blood or urine tests, liver ultrasoundNo serious adverse events
Patient Satisfaction 76% rated moderate-to-excellent satisfaction with single Rx 92% reported no pain or discomfort96% reported treatment time was acceptable
Teitelbaum et al. PRS ‘07
Multi-Center Controlled Clinical Trial UltraShape® Single-Treatment
Courtesy of Dr. S. Teitelbaum, Santa Monica, CA
UltraShape® Single-Treatment Results
Lower Abdomen
Pre-Treatment Post Treatment
Reduction 3.5 cm 3.5 cm
Courtesy of Dr. Jacques Otto, London, England
UltraShape® Single-Treatment Results
Lateral Thighs
Pre-Treatment 28 Days Post Treatment
Reduction 4.0 cm 4.0 cm
Position until 2005Available Information– Multi center study– Single treatment only– Subjects BMI = 26.5– Safety (blood test, urinalysis, liverultrasonography, skin and fat evaluation etc..)– Circumference reduction• Gaps– No data regarding multiple treatments– Insufficient data regarding patient satisfaction
SCANDINAVIAN AKADEMIKLINIKEN Study
2006 Per Hedén MD, PhD Chairman, Ass. Professor in Plastic SurgeryStockholm, Sweden - London, UK, - Copenhagen, Denmark - Oslo, Norway
Primary:To establish the safety and the efficacy of theUltraShape Contour I system multiple treatmentregimen.SecondaryTo evaluate the subjects tolerance and satisfactionrate to the Contour I multiple treatmentsTo evaluate the additive affect of multiple
treatmentsby the Contour I system
Scandinavian Study Design • Healthy Subjects• Age 18-45• Fat thickness of at least 2.5 cm prior 1sttreatment• Hairless Skin (or willing to shave prior thetreatment)• Commitment to adhere to the study
timeline
Exclusion Criterion • Pregnancy• Cardiac pacemaker//defibrillators• Skin diseases• Fat-soluble drug regimen within the last 30
days• History of blood coagulation problems• Depressed scars within the treatment area
Study Timelines • 24 Subjects• Three (3) treatment sessions, one month apart• Treatment area – abdomen• BMI normal – mostly deformations//bulges• FU period – every 2 weeks (Weeks 0, 2, 4, 6, 8,
10,12)• Last visit – 3 months after the last treatment
(week20)
Outcome parameters Safety Parameters• Adverse Events• Skin and fat evaluation• Pain during or following the treatmentsEfficacy Parameters• Circumference reduction• Photos• Patient satisfaction questionnaires (prior 1sttreatment and at weeks 4, 8, 12 and 20)
Measuring Parameters
UltraShape™
Non-invasive Lipolysis Using UltraShape™ Focused Ultrasound Ascher B, Paris, France
American Society for Aesthetic Plastic Surgery (2007) International Masters Course of Aging Skin (2007)
130 patients: abdomen, flanks, thighs 3 Treatments @ 30 day intervals 92% experienced measurable circumference reduction 73% 2-7cm circumference reduction Well tolerated with no patient related serious adverse events
• 1 blister, no sequela 88% rated moderate-to-very good satisfaction
Photos courtesy of Dr. Benjamin Ascher, Paris
Pre-Treatment 3 months Post Treatment
Reduction 5.0 cmWeight change -1.0 kg
Abdomen
UltraShape™ Three Treatment Results
“Lipotripsy” Non-invasive Ultrasonic Selective Destruction of Adipocytes using UltraShape™ Focused Ultrasound” Leal-Silva H, Monterrey, Mexico
American Society of Dermatologic Surgeons (2007) World Congress of Dermatology (2007)
36 patients: abdomen, flanks, thighs 3 Treatments @ 30 day intervals
100% experienced measurable circumference reduction 2 inch (5 cm) average reduction in body circumference CT scans (n=6) showed objective quantifiable fat thickness
reduction in 100% of cases No adverse events 94% rated satisfied-to-excellent satisfaction
BaselineTreated Area: AbdomenCircumference measure: 97.0 cmWeight 63.8 Kg
1 Mo FU after 3 TxTreated Area: AbdomenCircumference measure: 92.5 cmWeight 61.9 Kg
Circumference Reduction: 4.5 cm
Courtesy of Hector Leal-Silva, MD Monterrey, Mexico
Three Treatment Results
BaselineTreated Area: AbdomenFat Layer Thick: 4.9 cm
After 1 Tx Treated Area: AbdomenFat Layer Thick: 4.5 cm
Fat Thickness Reduction: .4 cm
Courtesy of Hector Leal-Silva, MD Monterrey, Mexico
One Treatment Results
BaselineTreated Area: AbdomenFat Layer Thick: 4.9 cm
After 2 Tx Treated Area: AbdomenFat Layer Thick: 4.2 cm
Fat Thickness Reduction: .7 cm
Courtesy of Hector Leal-Silva, MD Monterrey, Mexico
Two Treatment Results
1 Mo FU after 3 TxTreated Area: AbdomenFat Layer Thick: 3.8 cm
BaselineTreated Area: AbdomenFat Layer Thick: 4.9 cm
Circumference Reduction: 4.5 cmFat Thickness Reduction: 1.1 cm
Courtesy of Hector Leal-Silva, MD Monterrey, Mexico
Three Treatment Results
Personal Clinical Experience
July 2005 - October 2007500+ Patient Treatments
London Bridge Plastic Surgery
Three Treatment Results – All Sites
After Three Treatments
-8
-7
-6
-5
-4
-3
-2
-1
0
Treat 1 Treat 2 Treat 3
All Sites
-7.5 cm
Treatment ResultsCircumference reduction (mean)
Abdomen 8.5 cmLateral thighs 5.2 cmHips 4.5 cm
Average 6.3 cm
Photos courtesy of Dr. Chris Inglefield, London, UK
Abdomen
Pre-Treatment 1 month Post Treatment
UltraShape™ Single-Treatment Results
Reduction 4.5 cm 4.5 cm
Photos courtesy of Dr. Chris Inglefield, London, UK
Abdomen
Pre-Treatment 1 month Post Treatment
UltraShape™ Single-Treatment Results
Reduction 1.8 cm 1.8 cm
Photos courtesy of Dr. Chris Inglefield, London, UK
Lower Abdomen
Pre-Treatment Post Treatment
UltraShape™ Two Treatment Results
Reduction 5.6 cm 5.6 cm
Photos courtesy of Dr. Chris Inglefield, London, UK
Lower Abdomen and Flanks
Pre-Treatment Post Treatment
UltraShape™ Two Treatment Results
Reduction 4.5 cm 4.5 cm
Photos courtesy of Dr. Chris Inglefield, London, UK
Pre-Treatment 1-month Post Treatment
Reduction 6.7 cm 6.7 cm
Lower Abdomen
UltraShape™ Three Treatment Results
UltraShapeUltraShape®® CONTOUR 2 CONTOUR 2
New Illumination system: Video camera integrated into the
system Optimal illumination of treatment
zone Improved tracking Software controlled camera and
illumination systems
LED based technology Softer light for superior working
environment
State of the art design
UltraShapeUltraShape®® CONTOUR 2CONTOUR 2
Patient Info Screen
(Data Base)
Zebra Cross
(Determining the Shape of the
Treatment Area)
Selection of Boundaries of the Treatment Area
Once area is detected, the
number of nodes is
displayed
Markers Selection
Treatment
Blue indicates overlap of target and
the center of the transducer;
White X indicates good acoustic
contact
New Software and GUI
Patient positioning is important for:
Stability of the tracking system
Maintaining a flat treatment area. This allows full
transducer contact and assures ideal acoustic contact
Minimizing the interaction with adjacent bony areas
Lowering the probability of adverse events
Patient Positioning
CONFIDENTIALCONFIDENTIAL
Taping
To “re-gather” the fat into a
central treatment area, surgical
tape may be used to lift and
gather the tissue
Flank Area (small):
Position the patient so that he/she is lying on their side (lateral)
In order to improve treatment conditions, place a pillow underneath the other flank so that it will push the flank to be treated up to the same height as the pelvis
For the comfort of the patient, place an additional pillow between the patient's legs
Patient Positioning
CONFIDENTIALCONFIDENTIAL
Patient Positioning
Thigh Area:Patient in “frog”
position; customized pillows for better positioning
CONFIDENTIALCONFIDENTIAL
Teitelbaum et al. PRS
Blood and urine analysis performed: days 0, 1, 3, 7, 14, 21, 28, 56, and 84 post treatment
Lab Study Study Results
CBC No clinically significant changes
PT, PTT, INR No clinically significant changes
Electrolytes, BUN/Cr No clinically significant changes
LFT’s, Bilirubin, Albumin No clinically significant changes
Serum Lipids No clinically significant changes
CPK, calcium No clinically significant changes
Urinalysis No clinically significant changes
UltraShapeUltraShape®® Multi-Center Controlled Clinical Trial Multi-Center Controlled Clinical Trial Single-Single-
TreatmentTreatment