VESTAKEEP® PEEK - High Performance Engineering …€¦ · for implantation, Care-Grades for medical devices and Dental-Grades for permanent dental applications, are changing standards

VESTAKEEP® PEEKBiomaterials for Medical Applications

VESTAKEEP® PEEK is setting new standards

Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Our activities focus on the key megatrends health, nutrition, resource efficiency and globalization.

As a technology leader for high-perfor-mance polymers, Evonik supplies poly-ether ether ketone (PEEK) materials for the medical sector. VESTAKEEP® PEEK for medical applications including i-Grades for implantation, Care-Grades for medical devices and Dental-Grades for permanent dental applications, are changing standards for medical technology applications due to their outstanding biocompatibility and biostability.

If implants are to be trusted to perform, the materials they are made from must be both biostable and able to handle mechanical stresses. Historically, this was the exclusive domain of titanium, stainless steel or cobalt-chromium. However, more and more implants are being made of PEEK, which have many advantages over metal. VESTAKEEP® i-Grades have been created to fill these needs.

From its exceptional material pro-perties and performance capabilities, VESTAKEEP® PEEK is the material of choice for medical applications.

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Michael Smith, founder and CEO of K7 LLC attributed VESTAKEEP® PEEK’s durability as a key component in gaining FDA 510(k) clearance. “We could not be more pleased with the test results and material durability of VESTAKEEP® PEEK”, said Smith. “The inherent strength and added ductility have created new possibilities for our PEEK implant designs.”

Advantages at a glance VESTAKEEP® PEEK provides convincing advantages like:

• biocompatibility• biostability• sterilizationcompatible• resistanttochemicals•modulussimilartobone• metal-free • wearcomfortduetolightweight andlowthermalconductivity• nox-rayartifactsand/oradjustableopacity• injectionmoldingandextrusioncompatible•lowwaterabsorption•easytomachine•goodprocessability•lowerstress-shieldingeffect

Customized for the human body Biocompatibility,biostabilityandsafetyareallmajorcriteriawhenamaterialisselected for a medical device or a medical implant.

Inanextensivetestingprogrammerunbyindependentcertifiedlabs,biocompa-tibilityhasbeentestedaccordingtoUSP<88>ClassVIandfollowingISO10993-1:2009guidelines.ThesetestresultsattesttoVESTAKEEP®’sexcellentbiocompatibilityandbiostability,whichareprincipallyattributedtothepolymers highchemicalresistanceandthermalstability.

VESTAKEEP® PEEK

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VESTAKEEP® Implant

VESTAKEEP®i-GradesareEvonik ssolutionforpermanentimplants.Theyarebiocompatible,haveexcellentmechanicalpropertiesandareextremelyreliable.TheextrahighpurityandextensivequalitymeasuresmakeVESTAKEEP®i-Gradesanidealmaterialforlong-termhumanimplants.Thespecialcombinationofper-formancecharacteristicsofVESTAKEEP®i-GradePEEKpolymersmakesthemthematerialofchoiceforimplants.Theyareusedfordifferentfieldsofapplicationsuchasspine,sportsmedicine,cardiovas-cular,cranial-maxillo-facial,orthopaedics,extremitiesorpharmacy.

X-ray transparency Traditionally,metalshavebeenthema-terialsofchoiceforspinalcagesandotherimplantsinthehumanbody,butrecentlythehigh-performancepolymerpolyetheretherketone(PEEK)hasprovenaseriousandevenmoredesirablealternative.Metalimplantsreachtheirlimitswhenitcomestotheimagingmethodsthatphysiciansuse,bothduringtheoperation,andtomonitorthehealingprocess.Becauseoftheirdensity,metalsabsorbx-raysandproduceartifactsontheradiographicimage.PEEK,however,istransparenttox-rays.Incaseswherethedoctordesirestoseetheimplant,x-rayopaquegradesofVESTAKEEP®arebeingdeveloped.

ElasticityAnotherweaknessofmetalsisthemodulusofelasticity,whichismuchhigherthanthatofbone.

Theimplantassumesalargeshareofthemechanicalload,therebyreducingthestressonthebone.Thisstress-shieldingeffectcanhavefar-reachingconsequences:Bonesneedthemechanicalstresstoberegeneratedinthehealingprocessand also remain strong. Elimination ofstressmayslowdownthehealingprocess,andovertheyears,weakenthebone,resultingingreatersusceptibilitytobonedeteriorationandbreakage.TheelasticityofVESTAKEEP®i-GradePEEKisclosertothecorticalboneandhasahigherelasticitythanmetals.Thisdetersthestress-shieldingeffectonboneandallowsforalonger,healthierlife.

Spine

Cranial-Maxillo-Facial

Cardiovascular

Pharmacy

Orthopaedics

Sports medicine

Extremities

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Biocompatibility tests VESTAKEEP® i-Grade

VESTAKEEP®

BiocompatibilitytestingaccordingtoISO10993for

i-Grade:Permanent implants

Dental-Grade:Permanentmucosalmembranecontact

Care-Grade:Bodyandbloodcontactupto30days

USP Class VI Acutesystemictoxicity/Intracutaneousreactivity/MuscleimplantationISO10993-5 Cytotoxicity Lot control Lot controlISO10993-10 Sensitization:maximizationtestaccordingtoMagnussonandKligmanISO10993-10 Sensitization:murinelocallymphnodeassay(LLNA)ISO10993-10 Irritation:intracuteneousreactivityISO10993-11 AcutesystemictoxicityISO10993-11 Subacute/Subchronicsystemictoxicity 14d/28d* 14daysISO10993-3 Genotoxicity:reversemutationassay(Ames)ISO10993-3 Genotoxicity:chromosomeaberrationtestISO10993-3 Genotoxicity:mouselymphomatestISO10993-6 Implantation tests Bone90days Muscle7days Muscle7days

Hemocompatibilitytesting *ISO10993-12 GC/MSfingerprint

*testedonVESTAKEEP®i-Graderesin

Application examples:•spinalcages•stents•heartvalves• facialimplants forfacialbone fractures

Spinal cages in different types

•accessports•sutureanchors•interferencescrews•smalljoints

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IndentaltechnologyPEEKprovidesametal-freesolutionforoutstandingwearcomfort.Theinnovativepolymerisusedforcrowns,bridges,andremovableandpermanentdenturesalike.PEEKisoneofthehighlevelinnovativematerialsindentaltechnology.

VESTAKEEP®DentalPEEKproductsareavailableinawiderangeofnaturalcolorsincludingwhitepigmented,tooth-coloredandgingiva-colored.Theselectionofcolorsallowsaestheticsolutions.

VESTAKEEP® Dental

VESTAKEEP® PEEK for fixed and removable applications•crowns/bridges•cervicalgingivaformers • temporaryandpermanentabutments•attachmentrestorations•partialdentures/transversalconnectors•occlusalsplints•inlaybridges•telescopiccrowns•dentures(basis)•healingcaps

Crowns

Bridges

Partial dentures

Abutments

Barrestorations

natural white pigmented

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„ Within the limitation of a laboratory study, the results suggest that biofilm formation on the surface of PEEK (VESTAKEEP® PEEK) is equal or lower than on the surface of conventionally applied abutment materials such as zirconia and titanium.“

Extractofthestudy„Biofilmformationonthesurface ofmodernimplantabutmentmaterials“bySebastianHahnel (DDS,PhD,UniversitätsklinikumRegensburg)etal.

HahnelS,WieserA,LangR,RosentrittM,Clin.OralImpl.Res.00(2014)1-5

More dental materialsDegacryl® www.degacryl.comNanocryl® www.evonik.com/hanse

tooth-colored gingiva-colored

Biocompatibility tests VESTAKEEP® Dental

VESTAKEEP®







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VESTAKEEP® Care

WhenitcomestoapplicationconditionsinvolvinghightemperaturesVESTAKEEP®Caregradesarethematerialsofchoice.

VESTAKEEP®CarePEEKproductsareavailableindifferentviscositiesforprocessingviaextrusionorinjectionmolding.

Theseductilegradesofferevenhigherresistancetoheat,chemicals,andhydrolysis.TypicalareasofapplicationforVESTAKEEP®Careincludepartsforhousingsandsurgicalinstruments,gearwheelsandotherpartsforfunctional

unitsanddurablemedicalequipment.Duetothematerial‘soutstandingtemperatureresistance,partsmadeoutof VESTKEEP® Care grades resist steam autoclavingforanextendednumberofautoclavingcycles.

Biocompatibility tests VESTAKEEP® Care-Grade

VESTAKEEP®







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Quality ManagementVESTAKEEPstockshapesareproducedunderanISO13485certifiedqualitymanagementsystem.Thematerialisreliablysuppliedataconsistentandquality.Allproductionisfullytraceableallitswaybacktotherawmaterialsusedfortheresinpolymerization.

VESTAKEEP® PEEK resins and stock shapesformedicalapplicationshavethoroughlybeentestedforbiocompati-bilityandtoxicitybasedonISO10993and USP <88> Class VI.

VESTAKEEP® Implant grades are ASTMF2026compliant.

Coating technologies

Quality and masterfiles

Coating technologies of VESTAKEEP® PEEK VESTAKEEP®PEEKhasbeenvalidatedinmultiplecoatingtechnologiese.g.titaniumonPEEKspinalcages.

Wecanprovidecontactinformationtodifferentcoatingcompaniesifinterested.

Masterfile strength Manufacturersrequirequickandpredic-tableregulatoryapprovaloftheirmedicaldevices.Evonikfiledmasteraccessfiles(MAF)forboththeVESTAKEEP®Implantgraderesinsandstockshapes.TheMAFscontaincomprehensivedatageneratedinhouseandalsoatindependenttestlaboratories.MAFsareupdatedregularlyasnewproductsaredevelopedandadditionaldataonexistingmaterialsareobtained.

Titanium coating on VESTAKEEP® PEEK enhances bone ongrowth

Coating on VESTAKEEP® PEEK is possible for many applications

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VESTAKEEP® medical product portfolio

VESTAKEEP® PEEK can be processed using all techniques such as injection molding, extrusion and the compression molding.

Combined, this means maximum freedom for the client and the best product for the patient for extreme mechanical, thermal and chemical requirements.

VESTAKEEP® rods diameter standardlengths 6- 20mm 3000mm25- 60mm 2000mm70-100mm 1000mm

VESTAKEEP® plates

availableindifferentdimensions•thicknessupto60mm•widthupto500mm

VESTAKEEP® Dental grades areadditionallyavailableasdiscsinmultipledimensions:

VESTAKEEP® discs

availableindifferentdimensions•diameters98.5mm diameters84.5mm•thickness12-30mm

Otherdimensionsareavailableonrequest.

VESTAKEEP® medical grades are availableasrodstocksandplates:

Delivery forms stock shapes

VESTAKEEP® for medical applications

VESTAKEEP® grades Delivery forms resins

stock shapes color resins description processing

VESTAKEEP® Implant

––– naturalcoloredVESTAKEEP®i2GVESTAKEEP®i2P •standardviscosity

•injectionmolding•compoundingand compression molding

granules•suppliedin1kg,5kg or10kghobbockswith polyethyleneliners

powders•suppliedin10kghobbocks withpolyethyleneliners

VESTAKEEP®i4PLVESTAKEEP®i4R naturalcolored

VESTAKEEP®i4GVESTAKEEP®i4P •highviscosity

•injectionmolding•extrusion•compoundingand compression molding

VESTAKEEP®i5R naturalcolored VESTAKEEP®i5G •veryhighviscosity •extrusion

VESTAKEEP® Dental

VESTAKEEP®D4R naturalcolored VESTAKEEP®D4G •highviscosity•injectionmolding•extrusion

granules•suppliedin25kgboxes withpolyethyleneliners (2x12.5kg)

VESTAKEEP®DC4420R whitepigmented VESTAKEEP®DC4420G •highviscosity•injectionmolding•extrusion

VESTAKEEP®DC4450R tooth-colored VESTAKEEP®DC4450G •highviscosity•injectionmolding•extrusion

VESTAKEEP®DC4470R gingiva-colored VESTAKEEP®DC4470G •highviscosity•injectionmolding•extrusion

VESTAKEEP® Care

––– naturalcolored VESTAKEEP®M20G •standardviscosity •injectionmolding granules

•suppliedin25kgboxes withpolyethyleneliners (1x25kg)

––– naturalcolored VESTAKEEP®M33G-HP

•meltfiltratedhighpuritygrade

•mediumviscosity

•injectionmolding•extrusion•filmextrusion•smalldiametertubes

VESTAKEEP®M40R naturalcolored VESTAKEEP®M40G •highviscosity•injectionmolding•extrusion

R = rods PL = plates G=granulesP=powder

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VESTAKEEP® for medical applications

VESTAKEEP® grades Delivery forms resins

stock shapes color resins description processing

VESTAKEEP® Implant

––– naturalcoloredVESTAKEEP®i2GVESTAKEEP®i2P •standardviscosity

•injectionmolding•compoundingand compression molding

granules•suppliedin1kg,5kg or10kghobbockswith polyethyleneliners

powders•suppliedin10kghobbocks withpolyethyleneliners

VESTAKEEP®i4PLVESTAKEEP®i4R naturalcolored

VESTAKEEP®i4GVESTAKEEP®i4P •highviscosity

•injectionmolding•extrusion•compoundingand compression molding

VESTAKEEP®i5R naturalcolored VESTAKEEP®i5G •veryhighviscosity •extrusion

VESTAKEEP® Dental

VESTAKEEP®D4R naturalcolored VESTAKEEP®D4G •highviscosity•injectionmolding•extrusion

granules•suppliedin25kgboxes withpolyethyleneliners (2x12.5kg)

VESTAKEEP®DC4420R whitepigmented VESTAKEEP®DC4420G •highviscosity•injectionmolding•extrusion

VESTAKEEP®DC4450R tooth-colored VESTAKEEP®DC4450G •highviscosity•injectionmolding•extrusion

VESTAKEEP®DC4470R gingiva-colored VESTAKEEP®DC4470G •highviscosity•injectionmolding•extrusion

VESTAKEEP® Care

––– naturalcolored VESTAKEEP®M20G •standardviscosity •injectionmolding granules

•suppliedin25kgboxes withpolyethyleneliners (1x25kg)

––– naturalcolored VESTAKEEP®M33G-HP

•meltfiltratedhighpuritygrade

•mediumviscosity

•injectionmolding•extrusion•filmextrusion•smalldiametertubes

VESTAKEEP®M40R naturalcolored VESTAKEEP®M40G •highviscosity•injectionmolding•extrusion

R = rods PL = plates G=granulesP=powder

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First-class service from manufacturers of medical products

InadditiontotheattributesoftheVESTAKEEP®product,Evonikprovidesacomprehensiveserviceforthedeve-lopmentandimplementationofpolymertechnologies. We support our customer from start to finishintheirsearchfornewareasofinnovativeapplications.

Theserviceweofferincludesthefollowing:•researchexpertisefrom decadesofexperience•adviceonmaterialsselection, newmaterialdevelopment•supportandguidance in processing•technicalserviceforoptimizing themanufacturingprocess

customer uses VESTAKEEP® PEEK standard portfolio to develop e.g. spinal implant applications

Standard

standard production specification

regulatory support

product delivery

customer asks for customized geometries/colors

geometry /colors / properties

match a standard product

Customized solution

Customized solutions

Weofferawidestandardportfoliobutalsohelpourcustomerswithourmaterialcompetencetodevelopthenextgeneration medical implant applications.

VESTAKEEP® Service

geometry /colors / properties

customized solution required

review requirementspropose solution

provide prototype

customer specification

regulatory support

deliver customized product

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RESOMER®isthestateoftheartpolymerforthemanufacturingofbiodegradablemedicaldevices.Uniquepolymersmadeoflactide,glycolide,caprolactoneortrimethylenecarbonatewillprovidesuperiorpropertiestoyourdeviceforapplicationslike:Sportsmedicine,trauma,CMF,coronarystents,drugdepots,regene-rative medicine and medical coatings.

www.resomer.com

Resomer® biomaterial for bioresorbable implants

Advantages at a glance•highbiocompatibility•x-raytransparency•diversifiedproductportfolio•customsynthesiscapability

Resorbable interference screws for ACL fixation

Resorbable implantsmade of RESOMER®

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EUROPLEX® PPSU sheets 7 and VESTAKEEP® PEEK films

Our EUROPLEX® sheet materials are especially suitable for sterilizablecontainers and orthopedic applications. VESTAKEEP® films may be used as a sliding layer or electrical insulator in chemically demanding environments.

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PA (polyamide)/PEBA (polyetherblock amide) is used successfully as a catheter material because of its high bursting resistance. This is provided by the combination of flexibility and pliability, toughness and hardness.

Typical applications include: Catheters, housings, surgical instruments.

8 ROHACELL®

Medical table tops using ROHACELL® polymethacrylimide foam as the structural core are not only lighter, but much thinner. Their reduced mass means radiation levels required for radioscopy can be kept at a minimum, thereby exposing the patient to much less radiation and lowering health risks. Thinner table tops also reduce scatter radiation and provide x-ray images of much higher quality.

Typical applications include: table and couch tops for x-ray and CT scan machines, operating tables, mammography plates, fixation devicesfor x-ray therapy.

9 CYROLITE®, CYREX® and XT®

Acrylic based multi-polymer compounds for medical devices and packaging delivering excellent chemical and lipid resistance. Sterilizable, bondable, BPA free and antimicrobial grades are available.

Typical applications include: medical consumables like e.g., luer locks, dialyzer housings, protection caps and covers, blood- and plasma- separators, collection and specimen vessels, connectors and injection ports, catheter accessories.

Product overview for medical devices

1 VISIOMER®

VISIOMER® UHP HEMA, MMA, HEMATMDI, EGDMA, TRGDMA:As one of the leaders in the production of Methacrylate monomers, Evonik offers highly purified hydroxyester and multifunctional methacrylates for the production of diverse medical products.

Typical applications include: Contact lenses, IOL, bone cements, dental fillings and dentures.

2 POLYMER and NANOCRYL®

POLYMER VS, RV, MV and NANOCRYL®: Evonik Hanse GmbH offers a wide ange of silicone and acrylic based materials which can be used in formulations for different medical products.

Typical applications include: dental impression, bite registrations,composite fillers, exoprothetics and cushionings.

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10 TROGAMID® Care

TROGAMID® Care is a highly trans-parent PA that is resistant to stress cracking. Because of its outstanding chemical resistance it is used especially in applications that come into contact with drugs and body fluids.

Typical applications include: Stopcocks, catheters, hearing aids, housings

11 DEGAPLAST®

Orthopedic exoprostheses provide high mobility and freedom of move-ment to disabled people. Besides metals, polymers play an important role here, too, with DEGAPLAST® based lamination systems occupying a prominent position, particularly in the handcrafting industry. DEGAPLAST® resins are methacrylate formulations based on MMA, solved PMMA, and special modifiers. The cured parts arethermoplastic and not brittle.

12 VESTODUR®

Specialty VESTODUR® are poly-butylene terephthalate compounds. They are easy to process and the moldings made of them are dimen-sionally stable.

Typical application include: Blood filters.

2 DEGACRYL®

Products of the DEGACRYL® range are PMMA polymers and copolymers distin guished by consistent quality with narrow specifications and superior free flowing properties. A broad portfolioallows choosing the suitable type for applications as in the dental and medical fields.

Typical applications include: Dentures, artificial teeth, bone cement.

3 VESTAKEEP® PEEK

Implants from VESTAKEEP® PEEK provide a new level of quality inmedicine: our PEEK polymers are used especially because of their outstanding biocompatibility and biostability.

Typical applications include: Spine, sports medicine, trauma, CMF,cardiovascular, drug ports, dental, medical textiles, ophthalmic, surgical instruments, housings.

4 RESOMER®

RESOMER® is the state of the art polymer for the manufacturing of bio-degradable medical devices. Unique polymers made of lactide, glycolide, caprolactone or trimethylene carbonate will provide superior properties to your device for applications like: Sports medicine, trauma, CMF, coro-nary stents, drug depots, regenerative medicine, medical coatings.

5 CYROLITE® MD PMMA

Acrylic Polymers for medical diagnostics applications requiringexceptional light transmittance and optical clarity. High flow for fast processing and multicavity tooling.

Typical application include: Diagnostic cuvettes, diagnostic testpacks, optical sensor view ports, crystallography trays, microfluidics,rotors.

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® registered trademarkThisinformationandanyrecommendations,techni-calorotherwise,arepresentedingoodfaithandbe-lievedtobecorrectasofthedateprepared.Recipi-entsofthisinformationandrecommendationsmustmaketheirowndeterminationastoitssuitabilityfortheirpurposes.InnoeventshallEvonikassumeliabil-ityfordamagesorlossesofanykindornaturethatresultfromtheuseoforrelianceuponthisinforma-tionandrecommendations.EVONIKEXPRESSLYDISCLAIMSANYREPRESENTATIONSANDWAR-RANTIESOFANYKIND,WHETHEREXPRESSORIMPLIED,ASTOTHEACCURACY,COMPLETE-NESS,NON-INFRINGEMENT,MERCHANTABILI-TYAND/ORFITNESSFORAPARTICULARPUR-POSE(EVENIFEVONIKISAWAREOFSUCHPURPOSE)WITHRESPECTTOANYINFORMA-TIONANDRECOMMENDATIONSPROVIDED.Referencetoanytradenamesusedbyothercompa-niesisneitherarecommendationnoranendorse-mentofthecorrespondingproduct,anddoesnotim-plythatsimilarproductscouldnotbeused.Evonikreservestherighttomakeanychangestotheinfor-mationand/orrecommendationsatanytime,with-outpriororsubsequentnotice.

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Evonik Resource EfficiencyHighPerformancePolymers45764 MarlGermanyphone+49236549-9227fax+49236549-809227evonik-hp@evonik.comwww.vestakeep.comwww.evonik.com

Evonik CorporationHighPerformancePolymers299 JeffersonRoadParsippany,NJ07054United Statesphone+1973929-8000www.vestakeep.comwww.evonik.com

VESTAKEEP® PEEK - High Performance Engineering …€¦ · for implantation, Care-Grades for medical devices and Dental-Grades for permanent dental applications, are changing standards

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