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CLINICAL EFFECTIVENESS
• Inthepivotaltrial,SpaceOAR
patientsdidnotexperienceany
Grade2+rectaladverseevents
(e.g.,proctitis,rectalbleeding,
orfecalincontinence)1,4
• 2xmorelikelytomaintain
baselinesexualfunction2,3
• Significantlyhigherpatient
reportedscoresforurinary
andbowelQualityofLife3,4
OPERATIONAL EFFICIENCY
• Straightforwardin-office
procedure
• Doesnotrequiregeneral
anesthesia
• Canbeimplantedwith
fiducialmarkerplacement
REIMBURSEMENT
Now with CPT® code 55874
ContactaSpaceOARReimbursement
Specialistat(781) [email protected].
SpaceOARhydrogelisanabsorbable,injectablematerialthatprovidesspacebetweentherectumandprostateinmenundergoingradiationtherapyforprostatecancer.
SpaceOAR® Hydrogel Innovativetechnologydesignedtoreducesideeffectsassociatedwithprostatecancerradiationtherapy
SpaceOAR® Application
Application Steps Ultrasound Image - Sagittal
NEEDLE PLACEMENT
• Attachprovided18Gneedletoaninjectablesaline-filled10ccsyringe
• Advanceneedletiptomidglandperirectalfat;checkinaxialviewtoensureneedletipismidlineforoptimalplacement
HYDRODISSECTION
• Slowlyinjectsalinetoexpand(hydrodissect)perirectalspace
• Aspiratetoensureneedleisnotintravascular
SPACEOAR HYDROGEL INJECTION
• Keepingthe18Gneedleinplace,removesalinesyringeandattachSpaceOARhydrogelapplicator
• Injecthydrogelslowlywithoutstoppingorpausing
• Removeanddisposeofneedle
Saline
SpaceOAR
Fat
Fat
Saline
SpaceOAR
Needle Needle
REQUIRED EQUIPMENT
• Side-fire(biplane)transrectalultrasound(TRUS)probe
• Stepper
NOTES:
• Aseptictransperinealrouteonly• Donotinjectifspacedoesnotopenwithsaline
PATIENT PREPARATION
• Bowelprep• Prophylacticantibiotics(recommended)
• Lithotomyposition• Anesthesia(perinstitutionalprotocol)
• Perinealskinprep
Sterile Prep Tray
• SpaceOAR Hydrogel • Saline • 10 cc Syringe
TRUS Probe in Stepper with Stand-off Balloon
Ultrasound and Monitor
Clinician
Clinician Assistant
SpaceOAR® Hydrogel Application Procedure
SpaceOAR® Application
Augmenix, Inc.201BurlingtonRoadBedford,MA01730
Tel:781.895.3235Fax:781.895.3236
ML042RevD
Augmenix,SpaceOAR,andSpaceOARlogoareregisteredtrademarksofAugmenix,Inc.CPTisaregisteredtrademarkoftheAmericanMedicalAssociation.PleaseseetheInstructionsforUse(IFU)foracompletelistofwarnings,risksandprecautions.
Product Code # Product Description
SO-2101 SpaceOAR® System
Intended Use: SpaceOARSystemisintendedtotemporarilypositiontheanteriorrectalwallawayfromtheprostateduringradiotherapyforprostatecancerandincreatingthisspaceitistheintentofSpaceOARSystemtoreducetheradiationdosedeliveredtotheanteriorrectum.1.Dataonfile2.Hamstra,DAetal.Sexualqualityoflifefollowingprostateintensitymodulatedradiationtherapy(IMRT)witharectal/prostatespacer:Secondaryanalysisofaphase3trial.PracticalRadiationOncology,Volume8,Issue1,e7-e15
3.Karsh,Letal.AbsorbableHydrogelSpacerUseinProstateRadiotherapy:AComprehensiveReviewofPhase3ClinicalTrialPublishedData.Urology,Publishedonline:November23,20174.Hamstra,DAetal.ContinuedBenefittoRectalSeparationforProstateRadiationTherapy:FinalResultsofaPhaseIIITrial.IntJRadiatOncolBiolPhys.2017Apr1;97(5):976-985.