Sonolith I Sys Brochure En

Power, accuracyand user-friendliness …… at your fingertip

You MasterYou Master Urology

We MasterTherapeutic Ultrasound

We MasterTherapeutic Ultrasound

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EDAP TMS - 4, rue du Dauphiné - PA La Poudrette Lamartine - 69120 Vaulx-en-Velin - FRANCETél : +33 (0)4 72 15 31 50 - Fax : +33 (0)4 72 15 31 51 - www.edap-tms.com - [email protected]

ISO 9001: 2000 • ISO 13485: 2003

EDAP TMS is the leader in therapeutic ultrasound. Having beenpresent in the market for 30 years, EDAP TMS (NASDAQ: EDAP)develops minimally-invasive therapeutic solutions for urology.

By consistently investing in research and development and byforming partnerships with internationally-renowned medical re-search institutions, EDAP TMS has been able to patentinnovative technologies.

EDAP TMS is present in many countries via an extensivenetwork of Subsidiaries and Distribution Partners. The Companyfocuses on producing a high standard of service for health carepractitioners: mobile equipment, training centers and a far-reaching maintenance network.

With Ablatherm® HIFU, EDAP TMS is the world leader in High In-tensity Focused Ultrasound (HIFU) for localized prostatecancer treatment.

The company is currently adapting this technology so that it ispotentially able to treat other types of tumors.

As a pioneer and key player in the field of extracorporeallithotripsy, EDAP TMS introduced the first modular lithotripterand owns the patent for Electroconductive® technology, utilizedin its Sonolith® range of ESWL systems.

EDAP TMS focuses every day on delivering technologies thatguarantee positive outcomes which are replicable, with low sideeffects and a preserved quality of life.

www.edap-tms.com

• Sonolith® 4000• Sonolith® 3000

Brochure i-sys 14 pag-09-05-12.qxp:Mise en page 1 25/09/09 11:02 Page 1

30 years of innovation in ESWLA long history of success

EDAP TMS has an impressive track recordof thirty years of innovation in TherapeuticUltrasound with a particular focus onESWL and HIFU (High Intensity FocusedUltrasound). Through technological,conceptual and clinical breakthroughs,EDAP TMS has revolutionized ESWL:the first patient membrane interface(replacing the bathtub), piezo-electrictechnology, in-line Ultrasound imagingand the modular lithotriptor conceptwere all introduced by EDAP TMS.

A recent addition to an alreadyimpressive patent portfolio, developedin conjunction with the INSERM, theFrench National Institute of Health andMedical Research, is ElectroConductiveLithotrispy (“ECL”). ECL is proprietaryto EDAP TMS and utilized on all of itslithotripters.

Worldwide presence for the fastestgrowing network of users

Number of EDAP TMS ESWL systems installed

Electroconductive Technology

Sonolith® i-sysSonolith® VisionSonolith® Praktis

LT 02LT 01

PiezoelectricTechnology

Electrohydraulic Technology

Sonolith® 4000Sonolith® 3000Sonolith® 2000Sonolith® 1000

Worldwide presence for the fastestgrowing network of users

Headquarters

Subsidiaries

Distributors

1979 2009


Highest stone free rate

Electroconductive technology:the new standard in ESWL

The finest fragmentation

The attributes to look for in modern shockwave technology are not only the ability to fragment stones, but morecritically, the ability to do so wherever possible in a single sitting without the patient returning for retreatmentand also to avoid steinstrasse. The unique and patented Electroconductive technology (ECL) utilized in theSonolith® i-sys is endowed with just the right combination of high pressure and focal size adaptability topulverize stones into fragments small enough to be eliminated naturally.The comparison below of residual fragments after the in-vitro fragmentation of a phantom stone (left) using anelectromagnetic shockwave generator (middle) and the Sonolith® i-sys ECL source (right) provides clearevidence of finer fragmentation… achieved with fewer shocks.

The best clinical results

EDAP TMS Electroconductive technology is clinically proven superiorcompared to other existing technologies:

A powerful and reliable principle

The patented Electroconductive technology isbased on a precisely controlled electricaldischarge in a highly conductive solution:• All electrical discharges are identical,• The origin (F1) of every shockwave is consistent,• Every shockwave is perfectly focused at thesame point (F2).

Uniform efficacy on allstone types and sizes

• Extensive range of settings• Variable energy density• Variable focal volume

Sonolith® Electroconductive technology

Electrohydraulic technology

Electromagnetic technology

Piezoelectric technology

%

81.5%

76,5%74%

Sono

lith®

Saltutti C, Di Benedetto A, et al. Extracorporeal lithotripters: is there a gold standard? In Vivo multifunctional compar-ison between 6 mobile devices. Congresso Nazionale AURO. IT, Roma, Italy, 2003

Finest fragmentation

94%

75%

90%86%

69%

50%

79%

40%

%

Sono

lith®

Sono

lith®

Initial stone fragmentation rate (%) Stone free rate at 3 month (%)

Ng C.F., Thompson T.J., McLornan L., and Tolley D.A., M.D. Sin-gle-Center Experience Using Three Shockwave Lithotripters withDifferent Generator Designs in Management of Urinary Calculi.Journal of Endourology, Volume 20, Number 1, January 2006.Nomikos M. S., Sowter S.J., Tolley D.A. Outcomes using a fourth-generation lithotripter: a new benchmark for comparison? BJUInternational. 2007

Lowest retreatment rate

%

14%

30%

20%

65%

45%

Nomikos MS, Sowter SJ, Tolley DA. Outcomes using a fourth-ge-neration lithotripter: a new benchmark for comparison?BJU international. 2007.Rassweiler J, Tailly G, Chaussy C. Progress in lithotriptortechnology. EAU Update Series. 2005;3:17-36.

Initialphantom stone

Residual fragments afterelectromagnetic shockwaves

(738 shocks average)

Residual fragments afterelectroconductive shockwaves

(427 shocks average)

Technologyby EDAP TMS

12 mm

10 mm

Automatic PressureRegulator

The exclusive Automatic Pressure Regulatormeasures and adjusts in real time the pressureat the focal point. This system ensures consis-tency shock after shock so every patient benefitsfrom the same treatment quality, month aftermonth.

Exclusiveby EDAP TMS

Exclusiveby EDAP TMS

Power

1% 73% 100%

"The results of treatments with the Sonolith® Electroconductivetechnology should be regarded as the new benchmark for thecomparative assessment of new-generation lithotripters."

Dr. David A. Tolley - The Scottish Lithotriptor Centre, Western General Hospital, Edinburgh - UK

Electricaldischarges

F2

F1

Electroconductive shockwave sourceVariable focal volume Stonefre

erate

at60

days

Retre

atmentrate


F2

170

mm

Leave no stone unturned

The unique design of the DIATRON IV generatoradapts to any situation and to any patient:

• Treatment depth up to 210 mm adapted to yourobese population,

• Easy reach of lower ureteric stones,• 290 mmwide aperture for patient comfort anddiffusion of pain at patient skin,

• 80° angle of aperture for larger acousticwindow,

• Flexible silicone membrane inflates and deflatesto accommodate all types of patients:pediatrics, bariatrics, etc.

The appropriate generatorposition

The motorized movement of the generator allowseasy pinpoint positioning every time:

• To find the best acoustic window,• To avoid gas pockets,• To treat from the side, from below or from anyintermediate position to adapt to the patientand his clinical condition.

Designed withthe patient in mind

ESWLby EDAP TMS

290 mm210

mm

80°

"We finally have the ability to treat kidney stoneson children as well as ureteric stones on obesepatients with a single lithotriptor."Pr. Xavier Martin - Head of Urology DepartmentEdouard Herriot University Hospital, Lyon - France

0° - 50°


All-isocentricrobotizedmouvements

90° proberotation

Automatic UltrasoundPositioning System (AUPS):the feel of freedom

The best acoustic window is never at thesame location. The exclusive AUPS systemof the Sonolith® i-sys gives the clinician thefreedom of movement to always find thebest viewing angle, and to keep the focuspoint at the center of the Ultrasound image.All movements are robotic to never losefocus on the stone.

155 mmwith electronic skinpressure control

Cranio-caudal andOrbital X-ray

Some clinical situations require lateralprojections, others require transverse.Equipped with a high-power 15kW generatorand high-resolution 23 or 31cm ImageIntensifier with latest technology 1k2 camera,Sonolith® i-sys offers motorized isocentricmovements in both projections, alwaysmaintaining the focal point in the center ofthe field of view.

-10/+30°orbital rotation

0 - 50°

+/- 25° cranio-caudalrotation

"The freedom afforded by the wide range of isocentric movementsprovides all the tools to visualize the stone with both X-rayand Ultrasound at the same time for any patient, whereverthe stone is located."Pr. Gerald Haupt - Head of Urology Department, St.-Vincentius-Hospital, Speyer - Germany

+/- 15° F2 rotation


Simultaneous dual imagingand treatment

Never has a lithotripter been so operatorfriendly. With the Sonolith I-sys, there is noneed to choose one imaging modality overthe other – shockwave generation, X-ray andUltrasound imaging can all be performedsimultaneously. No more dilemmas.

The machineadapts to you

No need to adaptto themachine

Stone-Locking System

TouchJust point the stone on the X-rayor Ultrasound image.

AimThe motorized patient supportautomatically brings the stoneto the appropriate location.

FireChoose your treatmentparameters and press the firebutton to obtain an effectiveand fine fragmentation.

123


Sonolith® i-sysadapts to every facility

Sonolith® i-sysadapts to every patient

Safety

In order to minimize exposure for the medical staff, Sonolith® i-sys can be entirely controlled froma mobile remote console behind a protective panel or from a control desktop in an adjacent room.All steps of the ESWL treatment can be operated remotely: the patient database, X-ray C-armmovements, Automatic Ultrasound Positioning System (AUPS), table displacement and the settingof treatment parameters. ESWL has never been so easy, safe and efficient.

Mobility

The Sonolith® i-sys can be configured as amobile and movable unit for mobilelithotripsy service or simply for inter-hospitalshared services.

Mobilityby EDAP TMS

Endo-urological proceduresWith a three-side access endo-urologicaltable, a carbon top and a full range ofaccessories, the Sonolith® i-sys doubles upas a veritable endo-urological workstation.

Safetyby EDAP TMS

Ergonomics and connectivity

Healthcare providers of the twenty-firstcentury face new challenges to get the mostout of new technology. The Sonolith® i-sysis DICOM 3.0 compatible thereby allowingfree-flowing transfer of data and imagesbetween devices and the hospital server.

DICOM

Endo-Uroby EDAP TMS


ESWLby EDAP TMS


You MasterYou Master Urology

We Master Therapeutic Ultrasound

We Master Therapeutic Ultrasound

Power, accuracy and user-friendliness …

… at your fingertip

Integ

rate

d

ESWL

100

81.5%

76.5%

74%

Elec

troco

nduc

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Tech

nolo

gy

Electroconductive®

Technology Electrohydraulic

Technology

Elec

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Electromagnetic Technology

Elec

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Sono

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10095.3%

82.4%

92.3%

83.1%

79.8%76.9%

50

Elec

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Elec

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tic T

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Elec

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Elec

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Elec

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Tech

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Elec

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Tech

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1-7 mm 8-12 mm >13 mm

Sono

lith®

Sono

lith®

Sono

lith®

Saltutti C, Di Benedetto A, et al. Extracorporeal lithotripters : is there a new gold standard ?In vivo multifunctional comparison between 6 mobile devices.Congresso Nazionale Auro, IT, Roma, Italy, 2003.

Pemberton RJ, Tolley DA. Comparison of a New-Generation Electroconductive SparkLithotripter and the Dornier Compact Delta for Ureteral Calculi in a Quaternary ReferralCenter. Journal of Endourology, vol 20 (10), October 2006 (732-736).

Using the Electroconductive® technologyin our lithotripters leads to:

� Highest stone free rate after 60 daysin 81.5% of patients

� Low re-treatment rate: 14%Electromagnetic technology: 20-30%Piezoelectric technology: 45-65%

� Greater efficacy whatever the stone size

Nomikos MS, Sowter SJ, Tolley DA. Outcomes using a fourth-generation lithotripter:a new benchmark for comparison ? BJU international. 2007.Rassweiler J, Tailly G, Chaussy C. Progress in lithotriptor technology.EAU Update Series. 2005;3:17-36.

… for optimum clinicalperformance

TMS

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Stone-free after 3 months (%)

Stone-free after 2 months (%)

EDAP TMS - 4, rue du Dauphiné - PA La Poudrette Lamartine - 69120 Vaulx-en-Velin - FRANCETél : +33 (0)4 72 15 31 50 - Fax : +33 (0)4 72 15 31 51 - www.edap-tms.com - [email protected]

ISO 900: 2000 • ISO 13485: 2003

EDAP TMS is the leader in therapeutic ultrasound. Having beenpresent in the market for more than 25 years, EDAP TMS (NASDAQ: EDAP) develops minimally-invasive therapeutic solutions for urology.

By consistently investing in research and development and byforming partnerships with internationally-renowned medicalresearch 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. TheCompany focuses on producing a high standard of service forhealth care practitioners: mobile equipment, training centersand a far-reaching maintenance network.

With Ablatherm® HIFU, EDAP TMS is the world leader in HighIntensity Focused Ultrasound (HIFU) for localized prostate cancer treatment.

The company is currently adapting this technology so that it ispotentially able to treat other types of tumors.

As a pioneer and key player in the field of extracorporeal lithotripsy, EDAP TMS introduced the first modular lithotripterand owns the patent for Electroconductive® technology, utilizedin its Sonolith® range of ESWL systems.

EDAP TMS focuses every day on delivering technologies thatguarantee positive outcomes which are replicable, with lowside effects and a preserved quality of life.

www.edap-tms.com

Brochure I-Sys A4 3 vol_07-11-23_UK.qxd 27/03/08 11:55 Page 1

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Sonolith I Sys Brochure En