PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... ·...
Transcript of PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... ·...
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Trinity ELITE®
Allograft with Viable Cells with FIBERLOCK™
Technology EXCEPTIONAL HANDLING AND STAYING POWER. LOCKED IN.
PATH TO FUSION
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≤24Hours
48-72Hours
≤72Hours
≤96Hours
Receipt Of Tissue Proprietary ProcessingInitiated
Cryopreservation && Controlled
Rate Freezing
Largest RecoveryNetwork
MTF has first right of refusal with all their recovery partners.
Quantitative &qualitative
assessment ofbioburden testing
Taken immediately prior to cleaning
& disinfection
Depletes HSCs & Preserves MSCs, OPCs & bone-forming cells
FiberLock Technologyprovides a fully moldableallograft with viable cells
Controlled rateof 1ºC per minute
to -100ºC
Recovery
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12Months
≤72Hours
≤12Months
≤2Hours
Validated Shipping StorageStorage at MTFat -185ºC
Thawed forimplantation
Validated to ensure -70ºC temperaturesthroughout shipping
Expiration date of 1 year based on real time testing
Storage at UserFacility -70ºC to - 85ºC
Cell metabolismstops at -130ºC1
Storage timebased on real-time
testing
Up to 20% viability loss if other solutions are used
during thawing2
Two hour window of usage post-thaw since viability can be reduced up to 30-40% at
four hours2
Recommend D5LR foroptimal cell recovery
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www.orthofix.com1.800.535.44921.800.946.9008 (MTF)
TT-1622 © Orthofix Holdings, Inc. 5/2017
1. Mazur, P. Freezing of Living Cells: Mechanisms and Implications. Am. J. Physiol. 1984 Sep; 247 (3 Pt. 1): C125-142.
2. Data on File with MTF.
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FiberLock Technology
• Acts as a scaffold to provide bone-to bone contact for graft containment
• Withstands blood flow once implanted and resists washing away
• Interlocking fibers deliver versatile moldability and exceptional handling with no carrier added
A True Autograft Substitute
• Contains osteoconductive scaffold, osteoinductive signals and osteogenic cells
• Quality test criteria includes: - Minimum 70% cell viability - Osteoinductive Potential verified via BMP-2 content testing - Validated to contain a minimum of 500,000 cells per cc, of which
100,000 are MSCs, OPCs, and bone-forming cells
• Trinity ELITE allograft and its predecessor Trinity Evolution® allograft, have been implanted in more than 175,000 patients to date since 2009
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