spaceoar hydrogel · grade 2+ rectal adverse events (e.g., proctitis, rectal bleeding, or fecal...

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) 902-1657oratreimbursement@augmenix.com.

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

info@spaceoar.comwww.spaceoar.com

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.