marrowstim brochure bbi0017 0

7/27/2019 MarrowStim Brochure BBI0017 0

1/20

c o n c e n t r a t i o n s y s t e m

Concentrating the Power of Stem Cells

This brochure is for International use only. It is not for distribution in the United States.


2/204


Would you like to improve your Treatment by:

Improvingtissueregeneration?

Acceleratingwoundhealing? Reducingswelling?

Stimulatingbonehealing?

Reducingtheriskofinfection?

Do you recognize these problemsas a result of:

Delayed Wound Healing

Increasedriskofinfections

Soft Tissue Swelling

Pain

Longerimmobilisation

Decreasedrangeofmotion

Pseudarthrosis

Longerimmobilisation

Re-operation

Infection

Needforantibiotics

Re-operation

Leading to:

Highercosts

Morenursingcare

Longerhospitalstay

Increaseinnarcotics

Longerrehabilitation

Dissatisedpatients,surgeonsand nursingpersonnel

Revisions/surgicalfailure


3/201

Published literature has shown that:

The Proof

In Hard Tissue Bonemarrow-derivedstemcellscansignicantlyimproveboneformationincasesofbonenonunion13

Bonemarrow-derivedstemcellscansignicantlyreducejointpainandincreasejointfunctionin osteonecrosis45

Bonemarrow-derivedstemcell-enrichedallograftisaseffectiveasautograftwhenusedinbonegrafting andspinalfusionprocedures810

In Soft Tissue

Bonemarrow-derivedstemcellscaninducehealinginrecalcitrantchronicwoundsanddiabeticulcers1112

Bonemarrow-derivedstemcellscanhelprevascularizeanischemiclimb1416

Bonemarrow-derivedstemcellscanassistinvascularanastomosis17

Bonemarrow-derivedstemcellscanhelppreventscartissueformationandpreserveheartfunctionafter myocardialinfarction1819

In General

Bonemarrow-derivedstemcellscanreducemorbidity,bloodlossandoperatingtime20

Bonemarrowaspiratecontainswhitebloodcells,whicharecriticalinghtinginfection21


4/202


Thepresenceofstemcellsmakestheiliaccrestgraftveryappealing.Thisgraftprovidesthesurgicalsitewiththescaffold,cellsandsignalsnecessaryforsuccessfulbonehealing.However,graftsitemorbiditycoupledwithacomplicatedandtimeconsumingharvestmakeitdifculttojustifytheuseofthisgraftinmanydifferentprocedures.Asaresult,theuseofautologousbonemarrowaspirate(BMA)forbonegraftinghasbeenadvocatedasameanstoprovideanosteogeniccellsource.6TheMarrowstimConcentrationSystemenablesstemcellsfromtheiliaccresttobeeasilyandefcientlyconcentratedandtransferredtoasurgicalsitewithorwithoutgraftmaterial.TheabilityoftheMarrowstimdevicetorecoverandconcentratethenucleatedcellpopulationeasestheconcernofperipheralblooddilutionduringthemarrowaspiration.

Bonemarrowaspiratecontainsmesenchymalstemcells,whichareabletoproliferateanddifferentiateintoanumberofdifferentsoftandhardtissues.UtilisingMarrowstim technology,thesestemcellscanbeconcentratedatthepatientspointofcare.Clinicalevidencesuggestscellularconcentrationpositivelyaffectstheclinicaloutcomeofbonegraftingprocedures.1,20

Marrowstim Concentration System is the next generation

in hard and soft tissue grafting.

Why nucleated cell concentrate?

MesenchymalCells

Oste

ob

last

s

Bone

Cartilage

Connective

Tissues

Muscle

Tendon/Ligament

Fibroblasts

Myocytes

Cho

ndro

cyte

sFibrobla

sts


5/203

What is the Marrowstim Concentration System?

MarrowstimConcentrationSystemusesaproventechnologytoconcentratepowerfulstemcells,whichare

obtainedwiththeMarrowstimaspirateneedle.Thisuserfriendlykitprovidesallcomponentsneededtoobtainconcentratedstemcells.

Marrowstim Concentration System consists ofProven Marrowstim Technology

Consistent6.1xconcentrationoftotalnucleatedcellscomparedtobaselinelevel21

79%recoveryoftotalnucleatedcells(TNCs)21

Consistent6.9xconcentrationofmononuclearcellscomparedtobaselinelevel21

80%recoveryofmononuclearcells21

15minutecentrifugationspinmakesimplementationfeasibleinapointofcaresetting

Histologicalsectionofnucleated

cell concentrate

Specially designed aspirate needle with the following features:

Five(5)holesplacedatthedistaltip,allowingforbetteraspiration

Stylet,withitstrocarpoint,makesitpossibletoeasilypenetratethe

bonemarrowcavity

Ergonomicallydesignedhandleenablesasafermaneuverability, sincetheforceneededtopenetratethebonemarrowcavityis homogenouslydistributedovertheentirepalmofthehandrather

than locally

Two(2)styletsforsurgeonconvenience

Histologicalsectionofbonemarrowaspirate

DistalTip

TrocarPoint

Handle


6/204


Step 1: Anticoagulation

RinseMarrowStimbonemarrowaspirateneedle,disposable andtwo30mlsyringeswithanticoagulanttoensureinner

surfacesarecoated.Thiswillpreventclottingofbonemarrowduringaspiration.Performoneofthefollowingtechniques.

Method 1:Heparinonlytechnique(heparinnotsuppliedinthesekits):

Draw3mlheparinsolution(1000U/ml)intoasterile30mlsyringe;ensuretheheparincoatstheentireinnersurfaceofthesyringeandsetaside.Draw10mlheparinsolution

intoasecondsterile30mlsyringe;ensuretheheparincoatstheentireinnersurfaceofthesyringe.RemoveinnertrocarfromBMAneedle.Attachthesecond30mlsyringetotheBMAneedleandprimewithheparin,ensuring3mlofheparinremainsinthe30mlsyringe.RemoveBMAneedleandreplacethetrocar.

Method 2:ACD-Awithheparincoatingtechnique(heparinnotsuppliedinthesekits):

HeparinCoating:

Draw10mlheparinsolution(1000U/ml)intoasterile30mlsyringe.Pullsyringeplungerbackcompletely,ensuringtheheparincoatstheentireinnersurfaceofthesyringe.Aftercoatingthesyringe,pushtheplungercompletelydownonsyringetodispenseallremainingheparin.Draw10mlheparinsolutionintoasecondsterile30mlsyringe.Pullsyringeplungerbackcompletely,ensuringtheheparincoatstheentireinnersurfaceofthesyringe.RemoveinnertrocarfromBMAneedle.Attachthesecond30mlsyringetotheBMAneedleandprimewithheparin,ensuringallheparinhasbeendispensedfromthesyringethroughtheneedle.RemoveBMAneedleandreplacethetrocar.

ACD-A:

Draw6mlACD-Aintoeachoftheheparincoated30mlsyringes.

For the Marrowstim Mini System, only one 30ml syringeof anticoagulated marrow is utilised.

Step 2: Prepare Patient

Aftersuitableanesthesiaisachieved,placethepatientinthelateraldecubitusposition.Usingsteriletechnique,preparetheskinwithantisepticanddrape.(Figure1)

Step 3: Position NeedleHoldtheneedlewithproximalendinpalmandtheindexngeragainsttheshafttowardthetip.(Figure2)

Marrowstim Concentration System Instructions

Cortical boneSpongybone

Marrow

Figure1

Figure2


7/205

Step 4: Advance NeedleUsinggentlebutrmpressure,advancetheneedle,rotatingitinanalternatingclockwise/counterclockwisemotion.Entranceintothemarrowcavityisgenerallydetectedbydecreasedresistance.Allofthesideholesatthedistalendoftheneedlemustbeintroducedintothemarrowcavitybeyondthecorticalbone,otherwiseairwithextrabonysofttissuemayappearwiththeaspiratedmarrow.(Figure3)

Step 5: Remove Stylet/Trocar

Onceneedleisinplace,removethestyletbypullingstraightout.(Figure4)

Step 6: Aspirate Marrow

FollowtheBMAneedlemanufacturerpackageinsert(steps79)toobtainatotalof60mlanticoagulatedbonemarrowaspirate(3mlheparinwith27mlBMAper30mlsyringeor6mlACD-Awith24mlBMAper30mlsyringe).(Figure5)

For the Marrowstim Mini System, only one 30ml syringeof anticoagulated marrow is utilised.

Figure3

Figure4

Figure5


8/206


Step 1: LoadEnsureBMAfromonlyonepatientisprocessedperspin.

UnscrewcaponcentreportNo.1andremovecapandgreenpackagingpost.(Figure1)

Slowlyloadbothaspiratelled30mlsyringes(6mlofACD-Aand24mlofbonemarrowaspiratepersyringeor3mlofheparinand27mlofBMApersyringe),foratotalof60mlofanticoagulatedmarrowintocentreportNo.1.(Figure2)

Mini Marrowstim Concentration System: Slowly loadone 30ml syringe of anticoagulated marrow into centreport No. 1.

Removeprotectivecoveronwhitetetheredcapanddiscard.

ScrewwhitecapontocentreportNo1.(Figure3)

Preparation of the Marrowstim andMini Marrowstim Concentration Systems

Figure1

Figure2

Figure3


9/207

Step 2: Balance

Pressredbuttontoreleaselidofcentrifuge.Openandplacethetubeintothecentrifuge.(Figure4)

Mini Marrowstim Concentrate Kit: If using the minikit, the purple mini buckets must be inserted into thecentrifuge.

InsertMarrowstimConcentrationSystemcounterbalancewith60mlofsterilesalineorasecondMarrowstimdisposablewithBMA(whenprocessingtwotubes)intooppositesideofcentrifuge.(Figure5)

Mini Marrowstim Concentrate Kit: Fill purple minicounterbalance with 30ml of sterile saline and place intoopposite side of centrifuge.

Figure4

Figure5


10/208


Step 3: Spin

Closelid.Setspeedat3200RPMandtimeto15minutes.Pressgreenbuttontostartspin.Oncespiniscompleted,pressredbuttontoreleaselidandopen.(Figure6)

RemoveMarrowstimtubefromcentrifugeandensureBMAhasseparatedintothreedistinctlayers.(Figure7).

Step 4: Cell Poor Plasma (CPP) Extraction

RemoveyellowcaponsideportNo.2andconnectasterile30mlsyringe.Invertthetubeandwithdrawthecellpoorplasma.(Figure8)

Figure6

Figure7:Nucleatedcellconcentrate(NCC)processed

withtheMarrowstimConcentrationSystem

Figure8

Cell PoorPlasma

Nucleated CellConcentrate

Red Blood Cells


11/209

Step 5: Suspend Nucleated Cell Concentrate (NCC)

Whileholdingthetubeintheuprightposition,shakevigorouslyfor30secondstosuspendthecellularelements.(Figure9)

Step 6: Nucleated Cell Concentrate (NCC) Extraction

RemoveredcapfromsideportNo.3andconnectasterile10mlsyringetoextractthenucleatedcellconcentrate.(Figure10)

Figure10

Figure9


12/2010


Application possibilities for MarrowstimConcentration System

Hard TissueBone Marrow Aspirate

Orthopedics

DelayedUnionandNonunion13,22

AvascularNecrosis4,5

SpinalFusion89,23

CartilageRegeneration2426

Bone Marrow Aspirate + Platelet-rich Plasma

Orthopedics Osteonecrosis32

BoneRegeneration7,33

Cranio/Maxillofacial

PeriodontalRepair3435

AlvedarBoneRegeneration3536

Bone Marrow Aspirate + Demineralized Bone Matrix

Orthopedics

DelayedUnionandNonunion7,20

BoneCysts2829

Bone Marrow Aspirate + Fibrin Sealant

Orthopedics

BoneRegeneration30

Soft TissueBone Marrow Aspirate

WoundHealing

ChronicWounds12

IschemicUlcers11

Cardiovascular Surgery

MyocardialInfarction1819

PeripheralVascularDisease1416

Bone Marrow Aspirate + Fibrin Sealant

VascularAnastomosis17

Nucleatedcellconcentrate,platelet-richplasma

andBonusDBMappliedtoabulanonunion.

NucleatedcellconcentrateandBonusDBMap-pliedtoakneerevision.

NucleatedcellconcentrateandBonusDBMinspinesurgery.

NucleatedcellconcentrateandBonusDBMappliedtoahiprevision.


13/2011

Liquid toBonus DBM Ratio

Application DeliveryHandling

Consistency

10cc: 10cc,5cc: 5cc or

1cc: 1cc

Percutaneousinjections,

Contained defects

Finebeadnozzle,BOS needle

Flowablegel

6cc: 10cc,3cc: 5cc or.6cc: 1cc

Standardpacking,Molding

Fine beadnozzle,Log

Putty

4cc: 10cc,2cc: 5cc or.4cc: 1cc

Verybloodyenvironmentswith

heavyirrigationLogonly Crunchy

Bonus DBM(with Stem Cells)

Traditional DBM

Scaffold Yes Yes

Signals Yes Yes

Cells Yes No

Nutrition Yes No

Marrowstim Concentration System and Bonus DBM

DBMisanidealbalancebetweenallograftandautograft.Itpromotesbonegrowthbyprovidingosteoinductivegrowthfactorsandanosteoconductivescaffold.TheMarrowstimConcentrationSystemprovidesconcentrated

stemcells,whichhavebeenadvocatedasameanstoprovideanosteogeniccellsourceinavarietyofprocedures.Thispowerfulcombinationprovidesthesurgeonwiththescaffold,cells,signalsandnutritionnecessaryforsuccessfulbonehealing.(Table1)

Patient-specifc demands require options

Surgeryisnotanassemblyline.Eachpatienthasspecicneeds.ThepowerfulstemcellsobtainedwithandconcentratedbytheMarrowstimconcentrationsystemcanbeeasilytransferredtohydratesynthetic,allograftandautograftboneinavarietyofmethods.Thisallowsthesurgeontocustomizeaccordingtotheapplication.ForusewiththeBonusDBM,thefollowingratiosshouldbeuseful,dependingonthedesiredhandlingcharacteristics.(Table2)

Table 1

Table 2


14/2012


UtilisingtheGPSIISystemthepatientsownplatelets,whichtravelthroughthebloodstream,canbecollectedintoahighlyconcentratedformula.Whenplateletsbecomeactivated,growthfactorsarereleased.

TGF-1

VEGF

FGF

PDGF

TGF-2

EGF

Platelet Derived Growth Factor (PDGF-aa,

PDGF-ab, PDGF-bb)

Stimulatescellreplication

Promotesangiogenesis

Promotesepithelialisation

Promotesgranulationtissueformation

Vascular Endothelial Growth Factor (VEGF)

Promotesangiogenesis

Fibroblast Growth Factor (FGF)

Promotesproliferationofendothelialcells andbroblasts

Stimulationofangiogenesis

Transforming Growth Factor (TGF-1, TGF-2)

Promotesformationofextracellularmatrix

Regulatesbonecellmetabolism

Epidermal Growth Factor (EGF)

Promotescelldifferentiationandstimulates

re-epithelialisation,angiogenesisand collagenaseactivity

Advantages of Adding Platelet-rich Plasma to Stem Cells

Theadditionofplatelet-richplasma(PRP)tobonemarrowaspiratehasbeenshowntostimulateproliferationofmesenchymalstemcellsin vitro.37,38In vivo,PRPadditiontobonemarrowstemcellsandallografthascontributedtobetterallograftintegrationandincreasedboneformation.39


15/2013

Description Catalog Number

Ordering Information

Biomet Biologics Manual Spray Applicator Kit (Tip not included) 800-0250

Two12mlSyringes Two1mlSyringes

TwoSyringeAssemblySets ThreeLiquidTransferCups

OnePlasticTrayCompletewithSterileDrape

Malleable Dual Cannula Tip 20 Gauge x 4 inch Length 800-0202


Blending Connector Tip Single Cannula 800-0204


Drucker 230 Volt 5060 Hz Centrifuge 755VES-230V

Graft Preparation System 800-0300

Biomet Biologics Standard Non-Sterile Counterbalance (Blue) 800-0508

Biomet Biologics Mini Non-Sterile Counterbalance (Purple) 800-0505

Biomet Biologics Spare Bucket Kit (Drucker Centrifuge; 2 Blue Buckets) 7431

Biomet Biologics Mini Spare Bucket Kit (Drucker Centrifuge; 2 Purple Buckets) 7433

5ml Bonus DBM 48-DBM1



Autologous Thrombin Spray Tip (Pack of 10; To be used with 800-0204) ST-3 Tip

SprayApplicator

Kit(8000250)

MalleableDualCannula

Tip20Gaugex4inchLength(8000202)20Gaugex7inchLength(8000203)20Gaugex10inchLength(8000206)

GraftPreparation

System(8000300)

BiometBiologicsSpareBucketKit

(7431[Blue])

BiometBiologicsMiniSpareBucketKit

(7433[Purple])

BlendingConnector

TipSingleCannula(Includestwo

FlexibleSheaths)(8000204)

BiometBiologicsStandard

andMiniNon-SterileCounterbalance

(8000508[Standard;Blue])

(8000505[Mini;Purple])

Drucker230

Volt5060HzCentrifuge

(755VES-230V)

5mlBonusDBM(48-DBM1)



AutologousThrombinSprayTip(ST-3Tip)

If autologous thrombin is needed, ordering information can be found in the Clotalyst Brochure (BBI0004).


16/2014


Description Catalog Number

Ordering Information

Marrowstim Standard Kit with 30 ml ACD-A 800-0613A

Contents:

OneDisposable60mlMarrowstim Tube

One10mlSyringe

Four30mlSyringes

One18GaugeCentesisNeedle

One18GaugeSafetyApheresisNeedle

One30mlBottleofACD-A

OneBoneMarrowAspirationNeedle

OneAdhesiveTape54Inch

Two2x2Gauze

FourSyringeTips

Provides 6ml of concentrated BMA from 60 ml of anticoagulated aspirate.

Marrowstim Mini Kit with 30 ml ACD-A 800-0612A

Contents:

OneDisposable30mlMiniMarrowstim Tube

One10mlSyringe

Three30mlSyringes

One18GaugeCentesisNeedle

One18GaugeSafetyApheresisNeedle

One30mlBottleofACD-A

OneBoneMarrowAspirationNeedle

OneAdhesiveTape54Inch

Two2x2Gauze

FourSyringeTips

Provides 3ml of concentrated BMA from 30ml of anticoagulated aspirate.

Standard Kit Contents:

(1)Marrowstim Tube

(1)30mlBottleof

ACD-A

(1)18Gauge

Needle

(1)10mlSyringe

(4)30mlSyringes

(1)BoneMarrow AspirationNeedle

(1)ApheresisNeedle

(2)2x2Gauze(1)AdhesiveTape

(4)SyringeTips


17/2015

1. Hernigou,P.,Poignard,A,Beaujean,F.,Rouard,H.Percutaneous autologousbone-marrowgraftingfornonunions.Inuenceofthenumber andconcentrationofprogenitorcells.Journal of Bone and Joint

Surgery (American).87(7):14307,2005. 2. Hernigou,P.,Mathieu,G.,Poignard,A.,Manicom,O.,Beaujean,F., Rouard,H.Percutaneousautologousbone-marrowgraftingfornonunions. Surgicaltechnique.Journal of Bone and Joint Surgery (American). 88 (Suppl1Pt2):3227,2006. 3. Connolly,J.,Guse,R.,Lippiello,L.,Dehne,R.Developmentofan osteogenicbone-marrowpreparation.Journal of Bone and Joint Surgery

(American).71(5):68491,1989. 4. Gangji,V.,Hazeur,J.P.,Matos,C.,DeMaertelaer,V.,Toungouz,M., LambermontM.Treatmentofosteonecrosisofthefemoralheadwith implantationofautologousbonemarrowcells.Apilotstudy.Journal of

Bone and Joint Surgery (American).86A(6):11531160,2004. 5. Hernigou,P.,Poignard,A.,Manicom,O.,Mathieu,G.,Rouard,H. Theuseofpercutaneousautologousbonemarrowtransplantationin nonunionandavascularnecrosisofbone.Journal of Bone and Joint

Surgery (British).87(7):896902,2005. 6. Block,J.E.Theroleandeffectivenessofbonemarrowinosseous regenerat ion.Medical Hypotheses.65(4):7407,2005. 7. Brodke,D.,Pedrozo,H.A.,Kapur,T.A.,Attawia,M.,Kraus,K.H.,Holy,C.E. et al.Bonegraftspreparedwithselectivecellretentiontechnologyheal caninesegmentaldefectsaseffectivelyasautograft.Journal Orthopedic

Research.24(5):85766,2006. 8. Muschler,G.F.,Matsukura,Y.,Nitto,H.,Boehm,C.A.,Valdevit,A.D., Kambic,H.E.,Davros,W.J.,Easley,K.A.,Powell,K.A.Selectiveretention ofbonemarrow-derivedcellstoenhancespinalfusion.Clinical

Orthopaedics and Related Research.432:24251,2005. 9. Muschler,G.F.,Nitto,H.,Matsukura,Y.,Boehm,C.,Valdevit,A.,Kambic, H.,Davros,W.,Powell,K.,EasleyK.Spinefusionusingcellmatrix compositesenrichedinbonemarrow-derivedcells.Clinical Orthopaedics

and Related Research.407:10218,2003.10. Tiedeman,J.J.,Garvin,K.L.,Kile,T.A.,Connolly,J.F..Theroleofa composite,demineralizedbonematrixandbonemarrowinthetreatment

of osseous defects. Orthopedics.18(12):115358,1995.11. Kohlman-Trigoboff,D.,Lawson,J.H,Murphy,M.P..Stemcelluseina

patientwithanischemicfootulcer:acasestudy.Journal of VascularNursing.24(2):5661.2006.

12. Badiavas,E.V.,Falanga,V.Treatmentofchronicwoundswithbone marrow-derivedcells.Archives of Dermatology.139(4):51016,2003.13. Bystrov,A.V.,Polyaev,Y.A.,Pogodina,M.A.,Rasulov,M.F., Krasheninnikov,M.E.,Onishchenko,N.A.Useofautologousbone marrowmesenchymalstemcellsforhealingoffreefull-thicknessskin graftinazonewithpronouncedhypoperfusionofsofttissuescausedby arteriovenousshunting.Bulletin of Experimental Biology and Medicine. 142(1):1238,2006.14. Tateishi-Yuyama,E.,Matsubara,H.,Murohara,T.,Ikeda,U.,Shintani, S.,Masaki ,H.et al.Therapeuticangiogenesisforpatientswithlimb ischaemiabyautologoustransplantationofbone-marrowcells:apilotstudy andarandomisedcontrolledtrial.Lancet.360(9331):42735,2002.15. Esato,K.,Hamano,K.,LiTS,Furutani,A.,Seyama,A.,Takenaka,H.et al. Neovascularizationinducedbyautologousbonemarrowcellimplantation inperipheralarterialdisease.Cell Transplant.11(8):74752,2002.

16. Higashi,Y.,Kimura,M.,Hara,K.,Noma,K.,Jitsuiki,D.,Nakagawa,K.et al.Autologousbone-marrowmononuclearcellimplantationimproves

endothelium-dependentvasodilationinpatientswithlimbischemia.Circulation.109(10):12158,2004.

17. Cardon,A.,Chakfe,N.,Thaveau,F.,Gagnon,E.,Hartung,O.,Aillet,S. et al.Sealingofpolyesterprostheseswithautologousbringlueandbone m arrow.Annals Vascular Surgery.14(6):54352.2000.18. Gao,L.R.,Wang,Z.G.,Zhu,Z.M.,Fei,Y.X.,He,S.,Tian,H.T.,et al. EffectofIntracoronaryTransplantationofAutologousBoneMarrow- DerivedMononuclearCellsonOutcomesofPatientsWithRefractory ChronicHeartFailureSecondarytoIschemicCardiomyopathy.American

Journal of Cardiology.98(5):597602,2006.19. Oakley,R.E.,Msherqi,Z.A.,Lim,S.K.,Lee,S.H.,Ho,K.T.,Sutandar,A. et al.Transplantationofautologousbonemarrow-derivedcellsintothe myocardiumofpatientsundergoingcoronarybypass.Heart Surgery

Forum.8(5):34850,2005.20. Connolly,J.F.Clinicaluseofmarrowosteoprogenitorcellstostimulate

osteogenesis.Clinical Orthopaedics and Related Research.355(Suppl): S257S266,1998.21. Welch,Z.R.,McKale,J.M.,Woodell-May,J.Citrate-basedAnticoagulant DoesNotHinderStemCellViabilityandConcentrationfromBoneMarrow Aspirate.Submittedat54thAnnualMeetingoftheOrthopaedicResearch Society.March25,2008.

22. Siwach,R.C.,Sangwan,S.S.,Singh,R.,Goel,A.Roleofpercutaneous bonemarrowgraftingindelayedunions,non-unionsandpoor regenerates.Indian Journal of Medical Sciences.55(6):32636,2001.23. Muschler,G.F.BoneGrafting.Physicians Weekly.21(15):19,2004.24. Adachi,N.,Ochi,M.,Deie,M.,Ito,Y.Transplantofmesenchymal stemcellsandhydroxyapatiteceramicstotreatsevereosteochondral damageaftersepticarthritisoftheknee.Journal of Rheumatology. 32(8):1615-18,2005.25. Wakitani,S.,Imoto,K,Yamamoto,T.,Saito,M.,Murata,N.,Yoneda,M. Humanautologouscultureexpandedbonemarrowmesenchymalcell transplantationforrepairofcartilagedefectsinosteoarthriticknees. Osteoarthritis Cartilage.10(3):199206,2002.26. JohnstoneB,YooJU.Autologousmesenchymalprogenitorcellsin articularcartilagerepair.Clinical Orthopaedics and Related Research. 367(Suppl):S156S162,1999.27. Sanchez,M.,Azofra,J.,Anitua,E.,Andia,I.,Padilla,S.,Santisteban,J.

et al.Plasmarichingrowthfactorstotreatanarticularcartilageavulsion:a casereport. Medical Science Sports Exercise.35(10):164852,2003.28. Docquier,P.L.,Delloye,C.Treatmentofaneurysmalbonecystsby introductionofdemineralizedboneandautogenousbonemarrow.Journal

of Bone and Joint Surgery (American).87(10):22538,2005.29. Rougraff,B.T.,Kling,T.J.Treatmentofactiveunicameralbonecystswith percutaneousinjectionofdemineralizedbonematrixandautogenous bonemarrow.Journal of Bone and Joint Surgery (American). 84A(6): 9219,2002.30. Yamada,Y.,Boo,J.S.,Ozawa,R.,Nagasaka,T.,Okazaki,Y.,Hata,K. et al.Boneregenerationfollowinginjectionofmesenchymalstemcellsand bringluewithabiodegradablescaffold.Journal of Craniomaxillofacial

Surgery.31(1):2733,2003.31. Chong,A.K.,Ang,A.D.,Goh,J.C.,Hui,J.H.,Lim,A.Y.,Lee,E.H.et al. Bonemarrow-derivedmesenchymalstemcellsinuenceearlytendon- healinginarabbitachillestendonmodel.Journal of Bone and Joint

Surgery (American).89(1):7481,2007.32. Centeno,C.J.,Kisiday,J.,Freeman,M.,Schultz,J.R.Partialregeneration ofthehumanhipviaautologousbonemarrownucleatedcelltransfer:a

case study. Pain Physician.9(3):2536,2006.33. Yamada,Y.,Ueda,M.,Naiki,T.,Takahashi,M.,Hata,K.,Nagasaka,T.

Autogenousinjectableboneforregenerationwithmesenchymalstem cellsandplatelet-richplasma:tissue-engineeredboneregeneration.

Tissue Engineering.10(56):95564,2004.34. Yamada,Y.,Ueda,M.,Hibi,H.,Baba,S.Anovelapproachto periodontal tissueregenerationwithmesenchymalstemcellsandplatelet-richplasma usingtissueengineeringtechnology:aclinicalcasereport.International

Journal of Periodontics and Restorative Denistry.26(4):3639,2006.35. Yamada,Y.,Ueda,M.,Naiki,T.,Nagasaka,T.Tissue-engineered injectableboneregenerationforosseointegrateddentalimplants.Clinical

Orthopaedics and Related Research.15(5):58997,2004.36. Oyama,T.,Nishimoto,S.,Takeda,M.Alveolarboneregenerationutilizing b-TCPandplatelet-richplasma(PRP)derivedfrombonemarrowaspirate. Annals of Plastic Surgery.54(2):2223,2005.37. Haynesworth,S.E.,Kadiyala,S.,Liang,L.,Bruder,S.P.Mitogenic stimulationofhumanmesenchymalstemcellsbyplateletreleasate suggestamechanismforenhancementofbonerepairbyplatelet concentrates.Transactionsofthe48thAnnualMeetingoftheOrthopaedic

ResearchSociety.42:0462,2002.38. Lucarelli,E.,Beccheroni,A.,Donati,D.,Sangiorgi,L.,Cenacchi,A., DelVentoA.M.et al.Platelet-derivedgrowthfactorsenhanceproliferation ofhumanstromalstemcells.Biomaterials.24(18):3095100,2003.39. Lucarelli,E.,Fini,M.,Beccheroni,A.,Giavaresi,G.,Di,B.C.,Aldini,N.N. et al.Stromalstemcellsandplatelet-richplasmaimproveboneallograft integration. Clinical Orthopaedics and Related Research.435:628,

2005.

References


18/2016


Biomet Biologics, Inc. 01-50-1436

P.O.Box587 Date:07/0756E.BellDrive

Warsaw,Indiana46581USA

MarrowStim and MarrowStim Mini Concentration Systems with ACD-A

ATTENTION OPERATING SURGEON

FOR INTERNATIONAL USE ONLY

NOTE: FOR SINGLE-USE ONLY. Discard the entire disposable system after

one use, using an acceptable method for devices potentially contaminatedwith blood products.

DESCRIPTION

MarrowStim Concentration System with ACD-A

TheMarrowStimConcentrationSystemwithACD-Aseparatesupto60mlofthe

patientsbonemarrowcomponentsbydensitythroughtheuseoftheMarrowStimcellseparator.

MarrowStim Mini Concentration System with ACD-A

TheMarrowStimMiniConcentrationSystemwithACD-Aseparatesupto30ml

ofthepatientsbonemarrowcomponentsbydensitythroughtheuseoftheMarrowStimMinicellseparator.

TheabovelistedsystemsaretobeusedwithacentrifugedistributedbyBiometBiologics,Inc.(BBI).

Heparin,utilizedintheanticoagulationstepoftheInstructionsforUse,isnotsuppliedinthesesystems.

MATERIALS

Thematerialsusedforsyringes,needles,tubing,connectors,andcellseparators

consistofmedicalgradepolymers,elastomersandstainlesssteelssuitablefor

useinmedicaldevices.

Allcomponentsinthesesystemsarepackaged,labeledandsterilizedasindicated

bytheirmanufacturerslabeling.

Allcomponentsinthesesystemsarelatex-free.

ACD-AisananticoagulantsuppliedbyCitraAnticoagulants,Inc.,Braintree,

MA,andmanufacturedbyCytosolLaboratories,Inc.,Braintree,MA.ForfurtherinformationregardingACD-AAnticoagulant,pleasecontactthesupplierat

1-800-299-3411.

TheACD-AprovidedisonlyforusewiththeMarrowStimandMarrowStimMini

ConcentrationSystems.

INDICATIONS FOR USE

TheMarrowStimandMarrowStimMiniConcentrationSystemswithACD-Aaredesignedtobeusedforthesafeandrapidpreparationofautologousconcentrated

bonemarrowaspirate(cBMA)fromasmallsampleofbonemarrowaspirateatthe

patientspointofcare.ThecBMAcanbeappliedtoasurgicalsiteorcanbemixedwithgraftmaterialpriortoapplicationtoasurgicalsiteasdeemednecessaryby

theclinicaluserequirements.

WARNINGS AND PRECAUTIONS

1. Singleusedevice.Donotreuse.

2. Usepropersafetyprecautionstoguardagainstneedlesticks.3. Donotusesterilizedcomponentsofthissystemifpackageisopenedor

damaged.4. UsepreparedcBMAwithin4hoursafteraspiratingbonemarrowfrompatient.

5. Thesurgeonistobethoroughlyfamiliarwiththeequipmentandthesurgical

procedurepriortousingthisdevice.6. Thepatientistobemadeawareofgeneralrisksassociatedwithbonemarrow

aspiration.Theserisksinclude,butarenotlimitedto:hemorrhage,seroma

formation,infection,and/orpersistentpainatthesiteofaspiration.7. Followmanufacturerinstructionswhenusingcentrifuge.UseonlyaBBI

centrifuge(IECcentrifugeorTheDruckerCompanycentrifuge).Outcomes

usingcentrifugesfromothermanufacturersareunknown.8. Followmanufacturerpackageinsertforthebonemarrowaspirate(BMA)

needle.

POSSIBLE ADVERSE EFFECTS

1. Damagetobloodvessels,hematoma,delayedwoundhealing,and/orinfection.2. Temporaryorpermanentnervedamagethatmayresultinpainornumbness.

3. Earlyorlatepostoperativeinfection.

4. Painatbonemarrowharvestsite.

STERILITYTheMarrowStimandMarrowStimMinicellseparatorsaresterilizedbyexposuretoaminimumdoseof25kGygammairradiation.AllotherMarrowStim

andMarrowStimMiniConcentrationSystemcomponentsaresterilizedbytheir

respectivesuppliersasindicatedontheirlabeling.Donotresterilize.Donotusepastexpirationdate.

INSTRUCTIONS FOR USE

NOTE: Use standard aseptic technique throughout the following procedures.

MarrowStim Concentration System

1. REMOVE:RemoveBMAneedlefromitssterilizedpackage.Removethe

innertrocarfromtheBMAneedle,andsetaside.2. ANTICOAGULATION: Perform ONE of the following techniques.

METHOD 1 (Heparin only technique):

Heparin:Draw3mlheparinsolution(1000U/ml)intoasterilized30ml syringe;ensuretheheparincoatstheentireinnersurfaceofthesyringeand

setaside.Draw10mlheparinsolutionintoasecondsterilized30mlsyringe; ensuretheheparincoatstheentireinnersurfaceofthesyringe.Attachthe second30mlsyringetotheBMAneedleandprimewithheparin,ensuring

3mlheparinremainsinthe30mlsyringe.RemoveBMAneedleandreplacethe trocar.

METHOD 2 (ACD-A with Heparin coating technique):

Heparin:Draw10mlheparinsolution(1000U/ml)intoasterilized30ml syringe.Pullsyringeplungerbackcompletely,ensuringtheheparin

coatstheentireinnersurfaceofthesyringe.Aftercoatingthesyringe,push

theplungercompletelydownonsyringetodispenseallremainingheparin. Draw10mlheparinsolutionintoasecondsterilized30mlsyringe.Pull

syringeplungerbackcompletely,ensuringtheheparincoatstheentireinner

surfaceofthesyringe.Attachthesecond30mlsyringetotheBMAneedle andprimewithheparin,ensuringallheparinhasbeendispensedfromthe

syringethroughtheneedle.RemoveBMAneedleandreplacethetrocar.

ACD-A:Draw6mlofACD-Aintoeachofthetwoheparin-coatedsyringes.3. ASPIRATION:FollowtheBMAneedlemanufacturerpackageinserttoobtain

atotalof60mlanticoagulatedBMA(3mlheparinmixedwith27mlBMAper

30mlsyringeOR6mlACD-Amixedwith24mlBMAper30mlsyringe),usingthe syringespreparedinthepreviousstep.

4. LOAD: ENSURE BMA FROM ONLY ONE PATIENT IS PROCESSED PER

SPIN, and that the cell separator remains upright.Unscrewcaponcenter

port#1ofthecellseparator.Removeanddiscardcapandgreenpackaging

post.Attachandslowlyloadboth30mlanticoagulated,BMA-lledsyringesone atatimeintocenterport#1.Unscrewanddiscardclearprotectiveinnerpiece

fromwhitecaptetheredtoport#1.Screwwhitecapbackontoport#1.Place

cellseparatorlledwithanticoagulatedBMAintotheBBIcentrifuge.5. BALANCE:Fillbluecounterbalancetube(800-0508)withanamountof

sterilizedsaline/waterequaltothatofBMAplusanticoagulantdispensedin thecellseparator.Placecounterbalancedirectlyoppositefromaspirate-lled

separatorincentrifuge.

6. SPIN:Closecentrifugelid.Setspeedfor3.2(x1,000rpm)andsetthetimeto 15minutes.Pressthestartbutton.Oncespiniscomplete,opencentrifugeand

removecellseparator.

7. EXTRACT PLASMA:Unscrewyellowcaponport#2,andsavecap.Connect sterilized30mlsyringe,tiltcellseparatortowardport#2,andextractplasma.

Removethe30mlsyringefromport#2,capwithasterilizedsyringecap,and setaside.Replaceyellowcaponport#2.8. SUSPEND cBMA:Holdingthecellseparatorintheuprightposition,shake

tubevigorouslyfor30seconds.

9. EXTRACT cBMA:ImmediatelyaftersuspendingthecBMA,unscrewthered caponport#3.Attachsterilized10mlsyringetoport#3,andextractthecBMA.

Removethe10mlsyringe,andcapwithasterilizedsyringecap.10.APPLY:ApplycBMAtosurgicalsite,withorwithoutgraftmaterialasrequired.

MarrowStim Mini Concentration System

1. REMOVE:RemoveBMAneedlefromitssterilizedpackage.Removetheinner

trocarfromtheBMAneedle,andsetaside.

2. ANTICOAGULATION:PerformONEofthefollowingtechniques. METHOD 1 (Heparin only technique): Heparin:Draw10mlheparinsolution(1000U/ml)intoasterilized30ml

syringe;ensuretheheparincoatstheentireinnersurfaceofthesyringe. AttachthesyringetotheBMAneedleandprimewithheparin,ensuring

3mlheparinremainsinthe30mlsyringe.RemoveBMAneedleandreplace

the trocar.METHOD 2 (ACD-A with Heparin coating technique):

Heparin:Draw10mlheparinsolution(1000U/ml)intoasterilized30ml syringe.Pullsyringeplungerbackcompletely,ensuringtheheparincoats

Package Insert


19/20

theentireinnersurfaceofthesyringe.Attachthe30mlsyringetotheBMA

needleandprimewithheparin,ensuringallheparinhasbeendispensed

fromthesyringethroughtheneedle.RemoveBMAneedleandreplacethe

trocar. ACD-A:Draw6mlofACD-Aintotheheparin-coatedsyringe.

3. ASPIRATION:FollowtheBMAneedlemanufacturerpackageinserttoobtain 30mlofanticoagulatedBMA(3mlheparinmixedwith27mlBMAOR6mlACD-A

mixedwith24mlBMA)usingthesyringepreparedinthepreviousstep.

4. LOAD: ENSURE MARROW FROM ONLY ONE PATIENT IS PROCESSED

PER SPIN, and that the cell separator remains upright.Unscrewcapon

centerport#1onthecellseparator.Removeanddiscardcapandgreen

packagingpost.Attachandslowlyloadthe30mlanticoagulated,BMA-lled syringeintocenterport#1.Unscrewanddiscardclearprotectiveinnerpiece

fromwhitecaptetheredtoport#1.Screwwhitecapbackontoport#1.Place cellseparatorintotheBBIcentrifuge.

5. BALANCE:Fillpurplecounterbalancetube(800-0505)withanamountof

sterilizedsaline/waterequaltothatofBMAplusanticoagulantdispensedin thecellseparator.Placecounterbalancedirectlyoppositefromaspirate-lled

separatorincentrifuge.

6. SPIN:Closecentrifugelid.Setspeedfor3.2(x1,000rpm)andsetthetimeto

15minutes.Pressthestartbutton.Oncespiniscomplete,opencentrifugeand removecellseparator.

7. EXTRACT PLASMA:Unscrewyellowcaponport#2,andsavecap.Connect sterilized30mlsyringe,tiltcellseparatortowardport#2,andextractplasma.

Replaceyellowcaponport#2.

8. SUSPEND cBMA:Holdingthecellseparatorintheuprightposition,shake

tubevigorouslyfor30seconds.

9. EXTRACT cBMA:ImmediatelyaftersuspendingthecBMA,unscrewthered

caponport#3.Attachsterilized10mlsyringetoport#3,andextractthecBMA. Removethe10mlsyringe,andcapwithasterilizedsyringecap.

10.APPLY:ApplycBMAtosurgicalsite,withorwithoutgraftmaterialasrequired.

These devices are only approved for distribution outside the United States.

MarrowStimandBiometBiologicsaretrademarksofBiometManufacturing

Corp.

CommentsregardingthesedevicescanbedirectedtoAttn:RegulatoryDept.,

Biomet,Inc.,P.O.Box587,Warsaw,IN46581USA,FAX:574-372-1683.

AuthorizedRepresentative: BiometU.K.,Ltd.

WatertonIndustrialEstate Bridgend,SouthWales

CF313XAUK

0086

01-50-1435

Tel.+39069201961Fax+39069275519

HSHOSPITALSERVICES.p.A.

GENERAL USE INFORMATION:

BoneMarrowTransplantationneedle.

WARNINGS AND PRECAUTIONS:

Thisdeviceisdesignedtobeusedbyaphysician.

Theseinstructionsarenotmeanttodeneorsuggestanymedicalorsurgical technique.Theindividualpractitionerisresponsiblefortheproperprocedure

andtechniquestobeusedwiththisdevice..

Checkiftheinnerpackageisunopenedanddamaged.Incaseofdamaged innerpackage,donotusetheproduct.

Checktheexpirydateandthegauge.

Possibleallergicreactionsshouldbeconsidered. Afteruseconsideritaswastematerial.

Storeinacoolanddryplace,protectfromlight.

Useofthedeviceisrestrictedonlytophysician. EthyleneOxidesterilized.

Sterilityandintegrityguaranteedonlyifobserved,withtheprescribedconditions.

Itmustbeusedonlyinhospitals.

INSTRUCTIONS FOR USE:

1. Aftersuitableanesthesiaisachieved,placethepatientintheventral

supineposition.2. Usingsteriletechnique,preparetheskinwithantisepticanddrape.

3. Holdtheneedlewiththeproximalendinpalmandtheindexngeragainstthe

shaftnearthetip.Thispositionstabilizestheneedleandallowsforbettercontrol.

4. Introducetheneedlethroughtheskinandbringitintocontactwiththeposterioriliac crest.

5. Usinggentle,butrmpressure,advancetheneedle,rotatingitinanalternating

clockwise/counterclockwisemotion.Entranceintothemarrowcavityis generallydetectedbydecreasedresistance.(Allofthesideholesatthedistal

endoftheneedlemustbeintroducedintothemarrowcavitybeyondthe

corticalbone,otherwiseairandextrabonysofttissuemayappearwiththe aspiratedmarrow).

6. Onceneedleisinplace,removethestyletbyrotatingtheuppersection90,

andpullingstraightout.7. Attachasyringewithaluertapertothehubofthebonemarrowharvestneedle

usingarmpushandtwistmotion.

8. Applysuctionbywithdrawingthesyringeplunger.Removethesyringewiththe

harvestedmarrow.9. Repeattheharvestprocedureuntilanappropriateamountofmarrowis obtainedtosatisfytheclinicalrequirement.

Sterile-Nonpyrogenic-Disposable

Sterileifunopenedandundamagedinnerpackaged

NOTFORUSE WARNING

0373

Theinformationcontainedinthesepackageinsertswascurrentonthedatethisbrochurewasprinted.However,thepackageinsertsmayhavebeenrevisedafterthatdate.Toobtaincurrent

packageinserts,pleaseusethecontactinformationprovidedherein.


20/20

AlltrademarkshereinarethepropertyofBiomet,Incoritssubsidiariesunlessotherwiseindicated.

This brochure is for international useonly,andisnotfordistributionintheUSA.

ThismaterialisintendedforsoleuseandbenetoftheBiometBiologicssalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.

ResponsibleManufacturer

BiometBiologics,Inc.ASubsidiaryofBiomet,Inc.P.O.Box58756E.BellDriveWarsaw,Indiana46581-0587USA

Tel.:+15742676639

AuthorizedRepresentativeBiometUK,Ltd.WatertonIndustrialEstateBridgend,SouthWales

CF313XAUK

www.biometbiologics.comwww.biometeurope.com

Distributedby

marrowstim brochure bbi0017 0

Documents