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Ablatherm® HIFU

Ablatherm® HIFU
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Ablatherm® HIFU

Product catalog summary
Introduction
EDAP TMS presents Ablatherm® HIFU, a High Intensity Focused Ultrasound technology for treating localized prostate cancer. This document outlines the specifications, procedures, and benefits of using HIFU technology.

Specifications and Technology
Ablatherm® HIFU offers precise and irreversible coagulation necrosis while preserving surrounding tissues. It supports three treatment protocols: first-line, repeat, and salvage treatment after External Beam Radiation Therapy (EBRT). The system provides early feedback via rapid PSA Nadir and is repeatable without increasing the Gleason score.

Robotic Assistance and Imaging
The system includes a computer-controlled robotic assistant with 3D micro-step movements and real-time visualization. It uses a 3 MHz EDAP TMS treatment transducer and a 7.5 MHz B&K imaging transducer. The Ablapak® and Ablasonic® systems ensure optimal ultrasound transmission and reduce prostate movements.

Safety and Efficacy
The technology is minimally invasive and radiation-free, requiring a short hospital stay and offering quick recovery. It provides uniform and reproducible clinical results with low morbidity and no late onset incontinence or impotence. The system includes automated safety features and a rectal cooling system.

Clinical Outcomes
HIFU is indicated for T1-T2 localized prostate cancer, especially for patients unsuitable for surgery. It is effective for local recurrence after EBRT or radical prostatectomy. The technology shows promising results as a salvage therapy with high negative biopsy rates and specific survival rates.

Quality of Life
HIFU treatment maintains a high quality of life with low morbidity and consistent clinical results. It minimizes severe rectal lesions and maintains potency in a significant percentage of patients.

Conclusion
EDAP TMS, a leader in therapeutic ultrasound, continues to innovate in minimally-invasive solutions for urology. With over 25 years in the market, the company focuses on delivering technologies that ensure positive outcomes with low side effects, preserving patients' quality of life.
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Catalog excerpts

Ablatherm® HIFU-1

HIFU INTEGRATED IMAGING Going the extra mile for your patients Move up a gear with ultrasound technology T R E AT I N G LOCALIZED P R O S TAT E CANCER HIFU - High Intensity Focused Ultrasound www.edap-tms.com

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Ablatherm® HIFU-2

AblathErnv Ablatherm® HIFU Going the extra mile for your patients High Intensity Focused Ultrasound Inserm Jointly developed by the French National institute tot^!*** ia Mec::ai: Psiea-ch (INSERM) ami CDAP TMS ™ma*Ma*m ► Precise and irreversible coagulation necrosis ► Preservation of surrounding tissues Right prostate lobe treatment • 3 treatment protocols (power algorithms) • First-line treatment • Repeat treatment • Salvage treatment after EBRT • Complete, partial or nerve-sparing treatment strategy ► Early feedback via rapid PSA Nadir (does not increase Gleason score) ► Does not preclude other...

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Ablatherm® HIFU-3

Take control of your new robotic assistant Real-time visualization during scanning and firing phases 3 MHz EDAP TMS treatment transducer 7.5 MHz B&K imaging transducer Computer controlled movements 3-dimensional Micro steps

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Ablatherm® HIFU-4

Automated safety features ► Easy monitoring from ► Patented fluid for optimal ultrasound transmission ► Closed system without contamination risk ► Rectal cooling system ► Reduce prostate movements

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Ablatherm® HIFU-5

State-of-the-art surgical robotic assistant Minimally-invasive – Radiation-free Short hospital stay (0-3 days) Spinal or general anaesthesia Quick recovery Quality of life [5] 50% 49% Range published in the literature since 2000 40 20 Quality of life Occurrence % 30 Low morbidity [3] 15% Consistent results in the litterature [1] [6] 7% [2] 2,3% 10 HIFU [a] [4] 5% 0% EBRT [b] No late onset incontinence or impotence Radical [b] Prostatectomy Incontinence 100 [a] excluding grade 1, [b] pad rate. [1] Ficarra et al, BJU Int. 2006 Dec;98(6):1193-8. [2] Chaussy and Thuroff Curr Urol Rep. 2003;4(3):24852....

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Ablatherm® HIFU-6

Ablatherm® HIFU Efficacy 100 80 Indications Range published in the literature since 2000 86% 86% 78% 93% 87% 88% 82% 85% 75% 83% 77% 2006 n=58 [9] 2006 n=30 [8] 2004 n=146 [7] 2003 n=175 [6] 2007 n=227 [4] Treatment for local recurrence after EBRT or radical prostatectomy 2003 n=120 [3] 20 2001 n=102 [2] First-line treatment for patients who are not suitable for surgery 2000 n=82 [1] 40 2003 n=96 [6] T1 – T2 localized prostate cancer 2003 (multicenter) n=402 [5] 60 0 Gelet, Poissonnier, Lyon Chaussy, Blana, Ficarra, Lee, Thüroff, Munich Regensburg Verona Seoul Negative biopsy rate 100% Range...

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Ablatherm® HIFU-7

State-of-the-art surgical robotic assistant Quality of life [5] 50% 49% Range published in the literature since 2000 30 No late onset incontinence or impotence 20 Occurrence % 40 [3] 15% [1] [6] 7% [2] 2,3% 10 HIFU [a] 5% [4] 0% EBRT [b] Radical [b] Prostatectomy Incontinence [5] 100% [a] excluding grade 1, [b] pad rate. [1] Ficarra et al, BJU Int. 2006 Dec;98(6):1193-8. [2] Chaussy and Thuroff Curr Urol Rep. 2003;4(3):24852. [3] Zelefsky et al, Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):11116; [4] Brabbins et al, Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):400-8. [5] Steineck et al, N...

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Ablatherm® HIFU-8

Ablatherm® HIFU Using the latest technology break Treatment preparation Consumable setting: Ablapak® • • • • Patented fluid for optimal ultrasound transmission Closed system without contamination risk Rectal cooling system Reduces prostate movements 00:10 Safety T°c Ideal patient positioning • No potential interference of the ultrasound by gas bubbles • Continuous Ablasonic® fluid degassing 00:15 Right lateral decubitus Safety Treatment protocol choice First-line treatment Institut national de la santé et de la recherche médicale • Clinically validated power algorithms jointly developed by the...

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Ablatherm® HIFU-9

Take control of your new robotic assistant kthroughs for each treatment step Treatment start Prostate volume scanning EDAP TMS 3 MHz • B&K imaging transducer (7.5 MHz / 128 elements electronic array) • Real-time visualization • 3D volume reconstruction 00:30 B&K 7.5 MHz Safety Intraoperative treatment planning • Variable lesion height: 19 to 26 mm • Rectum is completely excluded from the treatment area with a 3 to 8 mm safety distance 00:40 The prostate is fully treated with a single pass from the anterior to the posterior part Safety Automated treatment 01:00 Accuracy ± 1mm • Automated and precise...

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Ablatherm® HIFU-10

You Master Urology We Master Therapeutic Ultrasound By consistently investing in research and development and by forming partnerships with internationally-renowned medical research institutions, EDAP TMS has been able to patent innovative technologies. EDAP TMS is present in many countries via an extensive network of Subsidiaries and Distribution Partners. The Company focuses on producing a high standard of service for health care practitioners: mobile equipment, training centers and a far-reaching maintenance network. With Ablatherm® HIFU, EDAP TMS is the world leader in High Intensity Focused...

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