88

90

92

94

96

98

Rodriguez6 24 months

Atwell5 26 months

Littrup4 19 months

92%

Follow-up

E�cacy

94%

98%

Loca

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)

Cryotherapy has unique radiographic conspicuity of the ablation zone1 • Distincticeballvisibility2• Imageguidance(ultrasound,CTorMRI)providesdirectcontrolofthelocationandsizeoftheiceball• Realtimemonitoringoftheablationzone2optimizesadequatetissuecoverageandavoidsdamagetoadjacentstructures

The ablation zone is controllable and predictable with cryotherapy•Multipleneedleplacementtofullycoverthetumor3• Simultaneousneedleactivation3

Cryotherapy has excellent patient outcomes• Localtumorcontrolafterasingletreatment4,5,6• Durabilitywithlowincidenceoftumorrecurrence5

• Demonstrated95%effectivenessintargetedtumors6• Excellentsafetyandefficacyprofiles3,7,8• Nephron-sparingtreatment9,10withnoimpactonpostablativerenalfunction11

• Lowriskofmetastaticprogression12,13

Cryotherapy can be used to treat a range of tumor sizes and difficult locations3,14

• Cryotherapyzoneiswelldemarcated3• Iceballvisibilityforintraproceduralcontrolandmonitoring1,2,3

•Multipletumorscanbetreatedinonesession15

Cryotherapy has low complication rates• Rateofclinicallyimportantcomplications(CTCAE≥3)followingRCCcryotherapyislow4,5,6

ImagescourtesyofDavid J. Breen, MD,ClinicalRadiologyDepartment,SouthamptonUniversityHospital,Southampton,UK

Cryotherapya therapeutic option for

renal cell carcinoma

Rodriguez6Atwell5 Littrup4

0

1

2

3

4

5

6

7

iguez6Rodrill5AtwLittrupp4

RCC Cryotherapy Complications CTCAE ≥ 3

6%

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Indications for UseThe Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures; various Galil Medical ancillary products are required to perform these procedures. Galil Medical Cryoablation Systems are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. These Systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

A full list of specific indications can be found in the Galil Medical Cryoablation System User Manuals.

Contraindications There are no known contraindications.

Warnings / Precautions / Adverse EventsA thorough understanding of the technical principles, clinical applications, and risks associated with cryoablation procedures is necessary before using Galil Medical products to conduct cryoablation. Use of such products should be restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Galil Medical Cryoablation System.

A full list of the warnings, precautions, and adverse events can be found by referencing the respective device Instructions for Use document or Cryoablation System User Manual.

only

Cryotherapy is a minimally invasive procedure, with multiple benefits:• Lessbloodlossversussurgery10,11,16

• Shorthospitalstay10,11,17

• Shortrecoverytime10

• Lowmorbidityforrapidreturntoeverydaylife10

•Maybesuitableforpatientswhocannottolerategeneralanesthesia18,19

There is minimal intraprocedural pain with cryotherapy• LowerdoseofanalgesicsneededwithcryotherapythanwhenperformingRFablation19

• Increasedpotentialforprocedurecompletionaspatientscantoleratetheprocedure19• Canbeperformedunderconscioussedation4versusgeneralanesthesia

www.galilmedical.com

©2013GalilMedical,Inc.|MUC12-IVR198-03|Sept.2013

Galil Medical Inc.4364RoundLakeRoad

ArdenHills,MN55112

USA

Tel: +16512875000

+18776392796

Galil Medical Ltd.TavorBuilding1

Yokneam

Israel2069203

Tel:+972(4)9093200

References 1. BreenDJ,RailtonNJ.MinimallyInvasiveTreatmentofSmallRenalTumors:TrendsinRenalCancerDiagnosisandManagement.CardiovascInterventRadiol2010;33:896-908. 2. CorneliusF,BalageasP,LeBrasY,etal.Radiologically-guidedthermalablationofrenaltumours.DiagIntervImaging2012;93:246-261. 3. TatliS,AcarM,TuncaliK,etal.Percutaneouscryoablationtechniquesandclinicalapplications.DiagIntervRadiol2010;16:90-95. 4. LittrupPJ,AhmedA,AounHD,etal.CT-guidedPercutaneousCryotherapyofRenalMasses.JVascInterv2007;18:383-392. 5. AtwellTD,CallstromMR,FarrellMA,etal.PercutaneousRenalCryoablation:LocalControlatMean26MonthsofFollowup.JUrol2010;184:1291-1295. 6. RodriguezR,CizmanZ,HongK,etal.ProspectiveAnalysisoftheSafetyandEfficacyofPercutaneousCryoablationforpT1NxMxBiopsy-ProvenRenalCellCarcinoma.CardiovascInterventRadiol2011;34:573-578. 7. GuazzoniG,CestariA,BuffiN,etal.OncologicResultsofLaparoscopicRenalCryoablationforclinicalT1aTumors:8YearsofExperienceinaSingleInstitution.Urol2010;76(3):624-629. 8. AronM,KamoiK,RemerE,etal.LaparoscopicRenalCryoablation:8-Year,SingleSurgeonOutcomes.JUrol2010;183:889-895. 9. LucasSM,CadedduJA.TheImportanceofNephron-SparingFocalTherapy:RenalFunctionPreservation.JEndourol2010;24(5):769-774. 10. GoyalJ,SidanaA,GeorgiadesCS,etal.RenalFunctionandOncologicOutcomesafterCryoablationorPartialNephrectomyforTumorsinSolitaryKidneys.KorJUrol2011;52:384-389. 11. MuesAD,LandmanJ.Resultsofkidneytumorcryoablation:renalfunctionpreservationandoncologicefficacy.WorldJUrol2010;28(5):567-570. 12. SchmitGD,ThompsonRH,KurupAN.Percutaneouscryoablationofsolitarysporadicrenalcellcarcinomas.BJUIntl2012;doi:10.1111/j.1464-410X.2012.11230.x. 13. KunkleDA,UzzoRG.CryoablationorRadiofrequencyAblationoftheSmallRenalMass,AMeta-analysis.Cancer2008;113(10):2671-2680. 14. RosenbergMD,KinCY,TsivianM,etal.PercutaneousCryoablationofRenalLesionsWithRadiographicIceBallInvolvementoftheRenalSinus:AnalysisofHemorrhagicandCollectingSystemComplications.AmJRoentgenol2011;196(4):935-939. 15. DeCastroGJ,GuptaM,BadaniK,etal.SynchronousCryoablationofMultipleRenalLesions:Short-termFollow-upofPatientOutcomes.Urol2010;75:303-306. 16. HaramisG,GraversenJA,MuesAD,etal.RetrospectiveComparisonofLaparoscopicPartialNephrectomyVersusLaparoscopicRenalCryoablationforSmall(<3.5cm)CorticalRenalMasses.JLapAdvSurgTech2012;LaparoendoscAdvSurgTech

2012;22(2):152-157. 17. HaberGP,LeeMC,CrouzetS,etal.TumorinSolitaryKidney:LaparoscopicPartialNephrectomyvsLaparoscopicCryoablation.BJUIntl2012;109(1):118-124. 18. GuptaA,AllafME,KavoussiLR,etal.ComputerizedTomographyGuidedPercutaneousRenalCryoablationwiththePatientUnderConsciousSedation:InitialClinicalExperience.JUrol2006;175:447-453. 19. AllafME,VarkarakisIM,BhayaniSB,etal.PainControlRequirementsforPercutaneousAblationofRenalTumors:CryoablationversusRadiofrequencyAblation–InitialObservations.Radiol2005;237:366-370.