6
Trinity ELITE ® Allograft with Viable Cells with FIBERLOCK Technology EXCEPTIONAL HANDLING AND STAYING POWER. LOCKED IN. PATH TO FUSION

PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue

  • Upload
    lenga

  • View
    229

  • Download
    1

Embed Size (px)

Citation preview

Page 1: PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue

Trinity ELITE®

Allograft with Viable Cells with FIBERLOCK™

Technology EXCEPTIONAL HANDLING AND STAYING POWER. LOCKED IN.

PATH TO FUSION

Page 2: PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue

≤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

Page 3: PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue

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

Page 4: PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue

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.

Page 5: PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue

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

Page 6: PATH TO FUSION - Orthofix, Inc.web.orthofix.com/Products/Products/Trinity ELITE/Trinity-ELITE... · PATH TO FUSION ≤24 Hours 48-72 Hours ≤72 Hours ≤96 Hours Receipt Of Tissue