ViviGen® & ViviGen Formable® Cellular Bone Matrix

ViviGen is a cellular allograft intended for repair or reconstruction of musculoskeletal defects. ViviGen is being utilized in fusion, nonunion, and malunion for foot/ankle or long bone trauma in patients with compromised biology.6- 11* It is comprised of three components that work in tandem to deliver superior healing potential compared to MSCs.1,2,3

1. Osteogenic ( Lineage Committed Bone Cells)The processing of ViviGen removes bone marrowcomponents including Mesenchymal Stem Cells whileretaining the desirable bone cells (osteoblasts,osteocytes and bone lining cells).1

2. Osteoconductive ( Corticocancellous Chips)Provide a natural scaffold for cell attachment, migrationand proliferation.1

3. Osteoinductive ( Demineralized Bone)A patented demineralization process exposes natural growth factors within the bone matrix that recruit hostcells and stimulate bone forming activity.1*

Results from case studies are not predictive of results in other cases. Results in other cases may vary. ViviGen is a registered trademark of LifeNet Health.The third party trademarks used herein are the trademarks of their respective owners.

Vivigen

Features & Benefits

Osteogenic1

Contains viable, lineage committed bone cells that areable to proliferate in vitro post cryopreservation and thaw4

Osteoconductive1

Contains corticocancellous chips that provide a naturalscaffold for cell attachment, cell migration and cellproliferation1

Osteoinductive1

Demineralization of the cortical bone exposes thenatural growth factors within the matrix1

Safety

Every lot is aseptically processed and tested for sterilityusing USP <71>1

Packaging

The rapid heat transfer not only allows for all sizes tothaw in less than 5 minutes, but is also vital for cellviability5

Processing Time

ViviGen reaches cryopreservation within 72 hours maximizing cell viability 24 hours sooner than competitive products1

Maximized Cell Viability

The processing of ViviGen is focused on protecting viable, lineage committed bone cells from recovery to implantation1

Multiple Forms

ViviGen and ViviGen Formable provide a comprehensive solution to meet surgeons’ clinical needs

Resources

Supporting Documentation

Resources

ViviGen Clinical Compendium

ViviGen® & ViviGen Formable® Brochure

ViviGen®/ViviGen Formable® Sell Sheet- TRAUMA

Specifications

BL-1500-001   1cc 
BL-1500-002   5cc 
BL-1500-003   10cc 
BL-1500-004   15cc 
BL-1600-001   Small 
BL-1600-002   Medium 
BL-1600-003   Large 
BL-1600-004   X-Large 

References

  1. LifeNet Health Data on File DHF 12-008, DHF 15-001, CC#52268.
  2. Reichert et al. Ovine coritical osteoblasts outperformbone marrow cells in an ectopic bone assy. J Tissue EngRegen Med 2011; 5:831-844.
  3. Tortelli, et al. The development of tissue-engineeredbone of different origin through endochondral andintramembranous ossification following the implantationof mesenchymal stem cells and osteoblasts in a murinemodel. Biomaterials 2010; 31:242-249.
  4. Sachs, Chen. Osteogenic Potential of the ViviGen CellularComponent Results from In Vitro Studies.
  5. Chen. Advantage of ViviGen Packaging Results from InVitro Studies.
  6. 68-20-210: K. Apostle, “Surgical Repair of Open FemurFracture with Bone Loss Using ViviGen® Cellular BoneMatrix”, 2018.
  7. 68-20-224: A. Kaz, “Surgical Repair of a Tibial Metaphysial Defect Using ViviGen Formable® CellularBone Matrix”, 2019.
  8. 68-20-226: A. Kaz, “Surgical Repair of Severe Varus Ankle Deformity with Osteoarthritis Using ViviGenCellular Bone Matrix”, 2019.
  9. 68-20-227: A. Kaz, “Surgical Repair of a Nonunion Fracture at the Fifth Metatarsal Using ViviGen CellularBone Matrix”, 2019.
  10. 10. 68-20-237: W. Giessler, “Surgical Repair of a Delayed Union to the Radius Diaphysis Using ViviGen® CellularBone Matrix in a Division I Football Athlete”, 2019.
  11. 68-20-238: W. Giessler, “Salvage of Failed Wrist Arthroplasty Using ViviGen® Cellular Bone Matrix”, 2019.

ViviGen & ViviGen Formable are registered trademarks of LifeNet Health.

Indication Statement

ViviGen is intended for repair or reconstruction of musculoskeletal defects.

120443-190808 DSUS