HIFU Technology History ABLATHERM ® Device Treatment Ablatherm Ablatherm ® INTEGRATED IMAGING The The HIFU Treatment for Localized Prostate Cancer Exit

HIFU Technology History ABLATHERM ® Device Treatment

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment The device The probe Robotized Placement Scanning 3D imaging Planning Firing phase Ultrasound Final aspect End Ablatherm® HIFU : step by step

HIFU Technology History ABLATHERM ® Device Treatment Ultrasound Waves Generation Plane transducer Ultrasound waves emission by transducer electro-mechanical vibrations Tissue motion Tissue heating Acoustical pressure Physical Principle Treatment Description

HIFU Technology History ABLATHERM ® Device Treatment Focused transducer Emitting ultrasound waves Tissue heating Over 85°C Acoustical pressure Focused Ultrasound Waves Physical Principle Treatment Description

HIFU Technology History ABLATHERM ® Device Treatment Tissue Lesion Formation Thermal effects + Cavitation effects + Time exposure = Tissue lesion Temperature Simulation INSERM U 557 Temperature Simulation INSERM U 557 Thermal Dose Simulation INSERM U 557 Thermal Dose Simulation INSERM U 557 HIC Technology H IFU I NDUCED C AVITATION Physical Principle Treatment Description

HIFU Technology History ABLATHERM ® Device Treatment HIFUHYPERTHERMIA l High Temperature (>85 °C) l Short Time (< 5 Sec.) l Low Temperature (< 45 °C) l Long Duration (>1 Hr) Time Temp. Two different approaches to reach the destruction threshold : Temp. Time Local Increase of Tissue Temperature BPH CANCER Physical Principle Treatment Description

HIFU Technology History ABLATHERM ® Device Treatment Transducer Positioning Treatment Description Physical Principle Precise lesion positioning with dynamic focusing Sparing of surrounding tissue

HIFU Technology History ABLATHERM ® Device Treatment Lesion Distribution within the Prostate Each shot consists of a burst of ultrasound waves with a duration of 5 seconds The focal volume is very small: mm in length by 1.7 mm in diameter Treatment Description Physical Principle

HIFU Technology History ABLATHERM ® Device Treatment Lesion Distribution within the Prostate Treatment Description Physical Principle

HIFU Technology History ABLATHERM ® Device Treatment The firing head moves until the whole targeted volume is treated Lesion Distribution within the Prostate Treatment Description Physical Principle

HIFU Technology History ABLATHERM ® Device Treatment History of the Ablatherm® Project 1989: Preliminary experiments on rats kidneys and technology development 1990: Cancer treatment - feasibility: Dunning tumors 1991: Endorectal approach - feasibility: canine prostate 1993: Treatment efficacy - evaluation: PCa 1995: Device safety improvements 1996: European Multicentric Study 2000: Mark Ablatherm ® Maxis 2005: Mark Ablatherm ® Integrated Imaging

HIFU Technology History ABLATHERM ® Device Treatment CE Mark Ablatherm® Marked January 2000

HIFU Technology History ABLATHERM ® Device Treatment In excess 9000 treatments in 100 sites in Europe Patients treated with Ablatherm every year

HIFU Technology History ABLATHERM ® Device Treatment Ablatherm® HIFU

HIFU Technology History ABLATHERM ® Device Treatment Device Description RF Power Imaging and Firing System Electronics and safeties + Disposable Endorectal Probe Cooling Motors User Interface Command Module Treatment Module Probe Module Patient Support Computer Probe General Description

HIFU Technology History ABLATHERM ® Device Treatment 2 functions, 2 transducers integrated in ONE probe Imaging Treatment Endorectal Probe Real-time ultrasound imaging. 7.5 MHz high-definition image. Electronic array technology. A 3 MHz transducer. Dynamic positioning with respect to rectal wall. Wide opening. ProbeGeneral Description

HIFU Technology History ABLATHERM ® Device Treatment Integrated imaging 2 different transducers with an Integrated imaging 7.5 MHz probe High resolution imaging system ProbeGeneral Description

HIFU Technology History ABLATHERM ® Device Treatment Imaging & Treating Simultaneously From a transversal real-time image, the 7.5 MHz electronic ultrasound transducer can provide an accurate 3D reconstruction of the treatment area. Imaging Firing High-energy ultrasound waves are focused through the rectal wall to the targeted prostate area. ProbeGeneral Description

HIFU Technology History ABLATHERM ® Device Treatment Indications Positioning Treatment Summary Candidate for RPP EBRT failure Recurrence after previous HIFU

HIFU Technology History ABLATHERM ® Device Treatment Main Steps of a Treatment Probe preparation (Ablapak ® disposable) Patient installation (Immobilization) Prostate localization (Apex identification) - Longitudinal imaging - Transversal imaging Treatment (Safety controls) Patient removal Probe cleaning and disinfection Positioning Treatment Summary

HIFU Technology History ABLATHERM ® Device Treatment Patient Installation (Immobilization) Patient positioned in right lateral decubitus position Positioning Treatment Summary

HIFU Technology History ABLATHERM ® Device Treatment Patient Installation (Immobilization) Patient movement detector Positioning Treatment Summary

HIFU Technology History ABLATHERM ® Device Treatment Probe insertion Intra-rectal positioning Prostate localization (1) Positioning Treatment Summary

HIFU Technology History ABLATHERM ® Device Treatment Prostate localization (2) Probe insertion Robotized movements Positioning Treatment Summary If the video doesn’t start automatically click on the window

HIFU Technology History ABLATHERM ® Device Treatment Prostate localization (3) Automatic imaging phase 3D reconstruction Positioning Treatment Summary

HIFU Technology History ABLATHERM ® Device Treatment Prostate localization (4) Automatic imaging phase 3D reconstruction Positioning Treatment Summary If the video doesn’t start automatically click on the window

HIFU Technology History ABLATHERM ® Device Treatment Treatment (planning) Positioning Treatment Summary Treatment area programming Firing phase

HIFU Technology History ABLATHERM ® Device Treatment Treatment (planning) Positioning Treatment Summary Treatment area programming Firing phase

HIFU Technology History ABLATHERM ® Device Treatment Treatment (planning) Positioning Treatment Summary Treatment area programmingFiring phase If the video doesn’t start automatically click on the window

HIFU Technology History ABLATHERM ® Device Treatment Treatment (planning) Positioning Treatment Summary Treatment area programmingFiring phase If the video doesn’t start automatically click on the window

HIFU Technology History ABLATHERM ® Device Treatment Treatment (Safety Controls) Main safety features Power / Firing sequence Probe position Patient movement Rectum position Temperature Positioning Treatment Summary Exit