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HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
AblathermAblatherm®
TheThe HIFU Treatment
for Localized Prostate Cancer
HIFU TECHNOLOGY POWERED BY EDAPHIFU TECHNOLOGY POWERED BY EDAP
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Ultrasound Waves Ultrasound Waves GenerationGeneration
Plane transducerUltrasound waves emission
by transducer electro-mechanical vibrations
Tissue motionTissue
heating
Acoustical pressure
+ + +- - -
Physical Physical PrinciplePrinciple
Treatment Description
Technology
1 / 4
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Focused transducer
Emitting ultrasound waves
Tissue heatingOver 85°C
Acoustical pressure
Focused Ultrasound WavesFocused Ultrasound WavesPhysical Physical PrinciplePrinciple
Treatment Description
Technology
2 / 4
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Tissue Lesion FormationTissue Lesion Formation
3L/4 L/4
D
Thermal effects
+ Cavitation effects
+ Time exposure
= Tissue lesion
Physical Physical PrinciplePrinciple
Treatment Description
Technology
3 / 4
Temperature Temperature SimulationSimulation INSERM U 556INSERM U 556
Thermal Dose Thermal Dose Simulation Simulation INSERM U 556INSERM U 556
Lesion L = 24 mm max
D = 1.7 mm
HIC TechnologyHIC TechnologyHHIFUIFU I INDUCEDNDUCED C CAVITATIONAVITATION
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Local Increase of Tissue Local Increase of Tissue TemperatureTemperature
HIFU HIFU HYPERTHERMIAHYPERTHERMIA
High Temperature (>85 °C) Short Time (< 5 Sec.)
Low Temperature (< 45 °C) Long Duration (>1 Hr)
TimeTime
Temp.Temp.
Physical Physical PrinciplePrinciple
Two different approaches to reach the destruction Two different approaches to reach the destruction threshold :threshold :
Temp.Temp.
TimeTime
Treatment Description
Technology
4 / 4
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Transducer PositioningTransducer Positioning
Precise lesion positioning with
Dynamic Focusing
Physical Principle
Sparing of surrounding tissue
Treatment Treatment DescriptionDescription
Technology
1 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Lesion Distribution within the Lesion Distribution within the ProstateProstate
• Each shot consists of a burst of ultrasound waves with a duration of 5 seconds
• The focal volume is very small: 19-24 mm in length by 1.7 mm in diameter
• The firing head moves until the whole targeted volume is treated
Physical Principle
Treatment Treatment DescriptionDescription
Technology
2 / 2
Treatment SimulationTreatment Simulation
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
History of the Ablatherm History of the Ablatherm ProjectProject
• 1989: Preliminary experiments on rats kidneys
and technology development
• 1990: Cancer treatment - feasibility: Dunning tumors
• 1991: Endorectal approach - feasibility: canine prostate
• 1992: Treatment safety - evaluation: human B.P.H.
• 1993: Treatment efficacy - evaluation: PCa
• 1995: Device safety improvements
• 1996: European Multicentric Study
• 2000: CE Mark Ablatherm®
History
1 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
CE Mark AblathermCE Mark Ablatherm
CE Marked January CE Marked January 20002000
History
2 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Device DescriptionDevice DescriptionGeneral General DescriptionDescription
ER Probe
Device
1 / 1
RF Power
Imaging
and Firing
System
Computer
Electronics
and safeties
+ Disposable
Endorectal Probe
Cooling
Motors
Patient Support
User Interface
Command Command ModuleModule
Treatment Treatment ModuleModule
Probe Probe ModuleModule
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Imaging Position
Firing Position
Endorectal ProbeEndorectal Probe
The therapy transducer (focuses at
40 mm, operates at 3 MHz) and
the 7,5 MHz biplane imaging
probe are coupled in a latex
balloon filled with a coupling
fluid (AblasonicTM)
General Description
ER ER ProbeProbe
Device
1 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Imaging / Treatment Imaging / Treatment PositionPosition
The targeted prostatic volume
is localized with the bi-plan
ultrasound imaging probe
Imaging Position
Firing Position
High-energy ultrasound waves are
focused through the rectal wall
to the targeted prostate area
General Description
ER ER ProbeProbe
Device
2 / 2Click on one of the above
images for animation
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Main Steps of a Main Steps of a TreatmentTreatment
• Probe preparation (Ablapak® disposable)
• Patient installation (Immobilization)• Prostate localization (Apex identification)
- Longitudinal imaging- Transversal imaging
• Treatment (Safety controls)
• Patient removal• Probe cleaning and disinfection
SummarySummary Positioning
Treatment
Treatment
1 / 1
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Infra-red light
Reflector
Patient
Indicator light is ON
Patient Installation Patient Installation (Immobilization)(Immobilization)Summary PositioninPositionin
ggTreatment
Patient positioned in right lateraldecubitus position
Patient movement detector
Treatment
1 / 1
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Treatment (Safety Treatment (Safety Controls)Controls)
Main safety features
• Power / Firing sequence• Probe position• Patient movement• Rectum position• Temperature
TreatmeTreatmentnt
Summary Positioning
Treatment
Click on the above image for an animation of the control interface
1 / 1
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
MRI performed day 2 after HIFU MRI performed day 2 after HIFU SessionSessionImagingImaging PSA/
Follow-upConclusion
Effects
1 / 2
MRI shows the boundaries of the necrotic tissue
The treated area appears as a hypo-intense area
surrounded by a 6-8 mm thick ring of contrast
enhancement
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Tissue DevelopmentTissue Development
Complete destruction of
the glandular tissue due
to coagulation necrosis
lesion which reaches the
capsula and the
periprostatic fat
The necrotic prostatic tissue is replaced by a
fibrotic tissue (including the capsula)
48 hours
3 months
ImagingImaging PSA/Follow-up
Conclusion
Effects
2 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Typical PSA after Typical PSA after AblathermAblatherm
0
50
100
150
200
250
m-93 m-94 m-95 m-96 m-97 m-98 m-99date
1 HIFU Session
Last PSA 0.2 ng/ml
Negative Biopsies
Complete response after
one HIFU session
Nadir PSA reached at 3
months
Imaging Conclusion
PSA/PSA/Follow-upFollow-up
PS
A (
ng/
ml)
Effects
1 / 3
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Multiple Ablatherm Multiple Ablatherm SessionsSessions
0
5
10
15
20
25
30
35
40
45
50
nov-95 nov-96 nov-97 nov-98Date
PS
A (
ng/
ml)
2 HIFU Sessions
Positive Biopsies
Negative Biopsies
Last PSA
0 ng/ml
0,3 ng/mlPartial treatment at the first
session
In case of rising PSA, a second
HIFU session can be performed
PSA PSA Follow-upFollow-up
Conclusion
Effects
Imaging
2 / 3
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Before After
Available for analysis N= 491 N= 339
Mean 1.59 2.04
Paired difference from baseline 0.55
Typical PSA after AblathermTypical PSA after Ablatherm
Quality of life assessment (IPSS - QOL)*
Imaging Conclusion
PSA/PSA/Follow-upFollow-up
* Data collected in Munich (October 1, 2000)
• 52% of the patients with the same or an improved QOL
• Variation without clinical significance
• HIFU treatment does not adversely HIFU treatment does not adversely affectaffect
the patient’s QOLthe patient’s QOL Effects
3 / 3
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Clinical EffectsClinical EffectsImaging PSA/
Follow-upConclusiConclusionon
With Ablatherm®, the urologist:
obtains a complete necrosiscomplete necrosis of prostate tumors in the treated area without damaging the surrounding tissues, and without adversely affecting QOL
has an early assessmentearly assessment of the treatment efficacy (PSA nadir, histology…)
can repeatrepeat the treatment, since no maximum dose exists
Effects
1 / 1
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Evidence-based EfficacyEvidence-based EfficacyConclusion
Adverse Events
Results
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
Long TermEM Study Efficacy
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Evidence-based EfficacyEvidence-based EfficacyConclusion
Adverse Events
Results
Long TermEM Study Efficacy
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
Ref: C. Chaussy, S. Thüroff, G. Vallancien, W. Wieland, H.J. Kiel, A. Le Duc, F. Desgranchamps, J. de la Rosette, A. Gelet HIFU for the Treatment of Localized Prostate Cancer: Efficacy Results of the European Multicentric Study The Journal Of Urology, May 2001, Vol. 165, 5:388
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Patients included from 1995 to 1999, in 6 European sites:
A. Gelet, Lyon - FranceA. Gelet, Lyon - France
C. Chaussy, S. Thüroff, Münich - GermanyC. Chaussy, S. Thüroff, Münich - Germany W. Wieland, H.J. Kiel, Regensburg - GermanyW. Wieland, H.J. Kiel, Regensburg - Germany
G. Vallancien, Paris - FranceG. Vallancien, Paris - France
A. Le Duc, F. Desgranchamps, Paris - FranceA. Le Duc, F. Desgranchamps, Paris - France
J. de la Rosette, Nijmegen - The NetherlandsJ. de la Rosette, Nijmegen - The Netherlands
n = 559 patients
up to 51 months follow-upup to 51 months follow-up
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric StudyEM StudyEM Study Long Term
Results
Conclusion
Adverse Events
Efficacy
1 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
T1-T2 T3-T4
Orch./Hormonotherapy Prostatectomy
RX Failure
Mean age: 69 years (range 45 - 88)
n=402
n=35n=8n=104
n=10
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
STUDY POPULATIONSTUDY POPULATION
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
2 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
T1-T2 PopulationT1-T2 Population Patients baseline Patients baseline
characteristicscharacteristics
< 10
10 - 20
> 20
Total
PSA (ng/ml)
50.9%
33.0%
16.1%
100%
2 - 4/G1
5 - 7/G2
8 - 10/G3
Total
Gleason score
10.5%
73.2%
16.3%
100%
0
1
2
3
4
5
6
Total
# Positivebiopsy
samples0.7% (TURP)
28.4%
29.5%
19.6%
6.5%
4.6%
10.7%
100%
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
3 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Overall results observed in the T1 - T2 population
Negative biopsy Negative biopsy raterate
87.2%87.2%
Nadir PSA Nadir PSA ng/mlng/ml
25th 25th percentilepercentile
medianmedian
75th 75th percentilepercentile
afterafter complete treatmentcomplete treatment
0.00.0
0.10.10.40.4
after after
partial treatmentpartial treatment
0.10.1
0.60.6
2.22.2
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
4 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Low-risk patients: T1-T2a and PSALow-risk patients: T1-T2a and PSA 10 ng/ml and Gleason score 10 ng/ml and Gleason score 6 6
Intermediate-risk patients: T2b or 10 < PSAIntermediate-risk patients: T2b or 10 < PSA 20 ng/ml or Gleason sc. = 7 20 ng/ml or Gleason sc. = 7
High-risk patients: T2c or PSA > 20 ng/ml or Gleason score High-risk patients: T2c or PSA > 20 ng/ml or Gleason score 8 8
Stratification of the results according to the initialdisease-related risk level
Negative biopsy Negative biopsy raterate
Low risk Low risk patientspatients
Intermediate Intermediate risk patientsrisk patients
High risk High risk patientspatients
92.1%92.1%
86.4%86.4%
82.1%82.1%
EM StudyEM Study
Results
Long Term Conclusion
Adverse Events
Efficacy
Large Cohort: European Large Cohort: European Multicentric StudyMulticentric Study
5 / 5 The Journal Of Urology, May 2001
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Evidence-based EfficacyEvidence-based EfficacyConclusion
Adverse Events
Results
Long TermEM Study Efficacy
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
Ref: L. Poissonnier, A. Gelet et al. - Résultats du traitement par ultrasons focalisés transrectaux du cancer localisé de la prostate (120 Patients avec PSA à 10 ng/ml) - Progrès en Urologie, 2003, vol. 13, p. 60-72
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Long-term Follow-up: Results from Long-term Follow-up: Results from LyonLyon
Total population: n=120Total population: n=120
Clinical StageClinical Stage
Gleason ScoreGleason Score
Age (years)Age (years)
PSA Value (ng/ml)PSA Value (ng/ml)
Prostate Volume (cc)Prostate Volume (cc)
2 - 6:2 - 6: n = 77n = 777 - 10:7 - 10: n = n = 434371.2 71.2 5.3 5.3
5.67 5.67 2.47 2.47
33.6 33.6 15.5 15.5
Inclusion criteria:Inclusion criteria: Localized prostate cancer (T1-T2)Localized prostate cancer (T1-T2)HIFU: primary care for PCa treatmentHIFU: primary care for PCa treatmentInitial PSA Initial PSA 10 Ng/mL 10 Ng/mL
EM Study Long TermLong Term
Results
Conclusion
Adverse Events
Efficacy
1 / 3 Progrès en Urologie, 2001
T1: n = T1: n = 6161T2: n = T2: n = 5959
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Long TermLong Term
Results
EM Study Conclusion
Adverse Events
Efficacy
Long-term Follow-up: Results Long-term Follow-up: Results from Lyonfrom Lyon
Overall Disease Overall Disease Free Rate (DFR)Free Rate (DFR)FAILURE CRITERIONFAILURE CRITERION Positive random sextant Positive random sextant
biopsy biopsy (whatever the PSA level )
OROR (even if negative control biopsies)
– biochemical evidence ofbiochemical evidence of 3 3 consecutive rising in PSA consecutive rising in PSA levellevel
– PSA velocity > 0.75 ng/ yearPSA velocity > 0.75 ng/ yearMonths
Follow up: Follow up: UpUp to 96 months to 96 months Negative Biopsies: Negative Biopsies: 85.8%85.8% (103/120) (103/120) Nadir PSA < 0.5: Nadir PSA < 0.5: 75%75% (90/120) (90/120) Mean prostate volume: Mean prostate volume: 14.6 14.6 14.1 cc 14.1 cc
DFR
(%
)
2 / 3 Progrès en Urologie, 2003
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Long TermLong Term
Results
EM Study Conclusion
Adverse Events
Efficacy
Long-term Follow-up: Results Long-term Follow-up: Results from Lyonfrom Lyon
DFR according to the baseline Gleason ScoreDFR according to the baseline Gleason Score
DFR
%
Months3 / 3 Progrès en Urologie, 2001
p<0.05
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Evidence-based EfficacyEvidence-based EfficacyConclusion
Adverse Events
Results
Long TermEM Study Efficacy
Large cohort of patients: European Multicentric European Multicentric StudyStudy
Long term follow-up: Results from LyonResults from Lyon
Optimal Efficacy: Results from Munich Results from Munich
Minimal Morbidity: Results from Munich Results from Munich
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Optimal Efficacy: Results from Optimal Efficacy: Results from MunichMunich
Results
Long TermEM Study Conclusion
Adverse Events
EfficacyEfficacy
• Patients evaluable for PSA nadir and/or stability: n Patients evaluable for PSA nadir and/or stability: n = 104= 104• Mean follow-up: 1 yearMean follow-up: 1 year
Inclusion criteria:Inclusion criteria: Localized prostate cancer (T1-T2)Localized prostate cancer (T1-T2)HIFU : primary care for PCa HIFU : primary care for PCa
treatmenttreatmentFirst treatment session : 3 MHz - 5 First treatment session : 3 MHz - 5
secsec
Stability: ASTRO definitionStability: ASTRO definition Non stable PSA:Non stable PSA:
Biochemical evidence of 3 consecutive rising in PSA level
from nadir, measured at least 3 months apart1 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Results
Long TermEM Study Conclusion
Adverse Events
EfficacyEfficacy
Optimal Efficacy: Results from Optimal Efficacy: Results from MunichMunich
Negative Biopsy Negative Biopsy RateRate
88.9 88.9 %%
10th 10th percentilepercentile
30th 30th percentilepercentile
MedianMedian
70th 70th percentilepercentile
90th 90th percentilepercentile
0.000.00
0.000.00
0.000.000.280.28
2.102.10
Nadir PSA (ng/ml)Nadir PSA (ng/ml)
PSA Stability PSA Stability RateRate
84.1 %84.1 %
Results observed on the overall population:
2 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Evidence-based EfficacyEvidence-based EfficacyConclusion
Adverse Events
Results
Long TermEM Study Efficacy
Large cohort of patients : European Multicentric European Multicentric StudyStudy
Long term follow-up : Results from LyonResults from Lyon
Optimal Efficacy : Results from Munich Results from Munich
Minimal Morbidity : Results from Munich Results from MunichRef: C. Chaussy, S. Thüroff - High Intensity Focused Ultrasound: Complications and Adverse Events Molecular Urology, 2000, Vol. 4, 3:183-7
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Death (Intra and post-op)
Fistula Rectal wall burnHemorrhoïdal painStress incontinence
Grade I (average 27 days)
Grade II (average 32 days)
Grade III (TURP)
Urge incontinenceUrgencyUTIs
Significant hematuriaImmediate post-treatment retentionTotal erectile dysfunction
Ejaculation problems
Last 100 patientsLast 100 patientsEM StudyEM StudyAdverse EventsAdverse Events
Results
Long TermEM Study Conclusion
Adverse Adverse EventsEvents
Efficacy
Minimal Morbidity: Results from Minimal Morbidity: Results from MunichMunich
1 / 1 Molecular Urology, 2000
00000011
99 221100 771313001001002222100100
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Ablatherm is now an evidence-Ablatherm is now an evidence-based valuable treatment based valuable treatment optionoption
Results
Long TermEM Study ConclusiConclusionon
Adverse Events
Efficacy
Large cohort of patients studied
Long term follow-up available
Optimal efficacy proven
Minimal morbidity observed
Evidence-based EfficacyEvidence-based Efficacy
1 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
SituationSituation
Where are we today?Where are we today?
ABLATHERM is a treatment option with a proven ABLATHERM is a treatment option with a proven
efficacy and a low morbidityefficacy and a low morbidity
24 sites using an ABLATHERM in routine daily
practice in Europe
More than 3500 patients treated as of More than 3500 patients treated as of AprilApril 31, 31,
20032003
Results
Long TermEM Study ConclusiConclusionon
Adverse Events
Efficacy
2 / 2
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
IndicationsIndications
• • As a first choice therapyAs a first choice therapy
• • As a salvage therapyAs a salvage therapy
In case of local recurrence
LOCALIZED PROSTATE CANCER
Indications
1 / 1
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
BenefitsBenefits
• Non-Invasive: no port, no seeds, no radiation
• Effective: precise and definitive necrosis of the targeted area
• Early Feedback: nadir PSA after only 3 months
• Quality of Life: minimal side effects
• Repeatable: if needed at any time during follow up
• Adaptable: to the physician and the patient’s therapeutic goals
• No Therapeutic alternative options still open post Ablatherm
Impasse:
Benefits
1 / 1
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
PositioningPositioning
1. Offers unique therapeutic advantages versus other existing therapies
2. Can be used as first choice therapy as well as salvage therapy
3. Offers economic benefits versus other existing therapies
4. Allows the urologists to remain the sole therapist during the overall
patient management Positioning
1 / 1
The HIFU Treatmentfor Localized Prostate Cancer, that
HIFU
History
Technology
ABLATHERM
Treatment
Positioning
Benefits
Device
CLINICAL
Effects
Results
Indications
HIGHLIGHTS
Ablatherm®Ablatherm®
Positioning
The HIFU Treatmentfor Localized Prostate Cancer
